EMERGENCY RELIEF KIT SYSTEM
FDA 510(k) clearance K964029 · decided 1997-03-17
Clearance details
- K-number
- K964029
- Device name
- EMERGENCY RELIEF KIT SYSTEM
- Applicant
- Baxter Healthcare Corp
- Decision
- Unknown
- Date received
- 1996-10-07
- Decision date
- 1997-03-17
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- LRR
- Device class
- N
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mcgaw Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| WATER JEL BURN KIT (K952561) | Water-Jel Technologies, Inc. | 1995-07-14 |
| CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING (K940249) | Certified Safety Mfg., Inc. | 1994-10-03 |
| FIRST AID/TRUMA KIT (K941311) | Certified Safety Mfg., Inc. | 1994-06-14 |
| TICK-ATTACK(TM) KIT (K931058) | Mind Mechanics, Inc. | 1994-03-01 |
| VARIOUS KITS (K931634) | Polymint Industrial Co. , Ltd. | 1993-11-30 |
| SHAWNEE PRODUCTS KIT I (K921762) | Absentee Shawnee Bandage Group | 1993-01-06 |
| AUTO FIRST-AID KIT FOR AMERICA (K903393) | Hisler-Radke, Inc. | 1991-01-31 |
| COMBINATION 6X-MAGNIFIER AND TWEEZERS (K896413) | James Alexander Corp. | 1990-02-01 |
| ORIGINAL TICK KIT/1ST AID KIT (K895767) | Tick Kit, Inc. | 1989-12-22 |
| FIRST AID SURVIVAL KIT (K891483) | Elwyn, Inc. | 1989-05-11 |
| FIRST AID KIT, VARIOUS SIZES (K871376) | Fraass Survival Systems, Inc. | 1987-06-04 |
| KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE (K871501) | Fraass Survival Systems, Inc. | 1987-06-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |