DEXIDE DISPOSABLE PREP PAD
FDA 510(k) clearance K791167 · decided 1979-08-03
Clearance details
- K-number
- K791167
- Device name
- DEXIDE DISPOSABLE PREP PAD
- Applicant
- Dexide, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-06-25
- Decision date
- 1979-08-03
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- FRL
- Device class
- 1
- Regulation number
- 880.5300
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, 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 |
|---|---|---|
| STAY FRESH SKIN FOLD MANAGEMENT TEXTILE (K121898) | Quick-Med Technologies, Inc. | 2013-05-24 |
| INTERDRY SILVER (K110715) | Milliken Healthcare Products, LLC | 2011-11-04 |
| INTERDRY TEXTILE WITH SILVER (K061615) | Milliken Chemical | 2006-12-22 |
| CARAPACE STERILE COTTON BALLS (K931626) | Carapace, Inc. | 1993-12-02 |
| ICAN COTTON RAYON BALLS (K914081) | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| TRACH CLEANING TRAY (K811990) | Associated Medical Products Co. | 1981-07-27 |
| UTENSIL & PROCEDURE TRAYS (K810242) | American Hospital Supply Corp. | 1981-04-15 |
| MEDSPEC RAYON BALLS (K800277) | Medspec Corp. | 1980-03-12 |
| SURGITEK FOERSTER FACE LIFT BANDAGE (K800248) | Medical Engineering Corp. | 1980-02-19 |
| SURGITEK FOERSTER MAMMARY BANDAGE (K800249) | Medical Engineering Corp. | 1980-02-19 |
| SORBIES (K792295) | American Hospital Supply Corp. | 1979-12-20 |
| BREAST PAD (K792294) | American Hospital Supply Corp. | 1979-12-11 |
Recalls involving this device
No recalls on record reference this clearance.