BAUER & BLACK ARM SLING W/DETACH. POUCH
FDA 510(k) clearance K803212 · decided 1981-01-08
Clearance details
- K-number
- K803212
- Device name
- BAUER & BLACK ARM SLING W/DETACH. POUCH
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1980-12-17
- Decision date
- 1981-01-08
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- ILI
- Device class
- 1
- Regulation number
- 890.3640
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Washington, DC, 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 |
|---|---|---|
| MATRX, PYRAMID TRIANGLE BANDAGE (K912661) | Matrix Medica, Inc. | 1991-08-21 |
| ARM SLINGS (K831549) | Fred Sammons, Inc. | 1983-06-30 |
| SATO FAMILY FIRST AID KIT (K831706) | Food and Drug Service, Inc. | 1983-06-24 |
| VARIOUS ARM SLING (K823808) | Danek Medical, Inc. | 1983-01-14 |
| A.C. SPLINT (K823810) | Danek Medical, Inc. | 1983-01-14 |
| UNIVERSAL SLING, SLING & SWATHE (K823664) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| UNIVERSAL SLING, SLING & SWATHE (K823162) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| ORTHOPEDIC SOFT GOODS (K820590) | Abco Dealers, Inc. | 1982-03-26 |
| ARM SLING, POUCH TYPE (K812477) | Maddak, Inc. | 1981-09-14 |
| MADDACOMFORT SLING (K812478) | Maddak, Inc. | 1981-09-14 |
| LIMB HOLDER ARM SLING (K812480) | Maddak, Inc. | 1981-09-14 |
| ARM SLINGS (K812345) | Fred Sammons, Inc. | 1981-09-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |