AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
FDA 510(k) clearance K963293 · decided 1997-03-28
Clearance details
- K-number
- K963293
- Device name
- AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
- Applicant
- Augustine Medical, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1996-08-21
- Decision date
- 1997-03-28
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- MSA
- Device class
- 1
- Regulation number
- 878.4020
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Eden Prairie, MN, 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 |
|---|---|---|
| MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (K020077) | Augustine Medical, Inc. | 2002-01-31 |
Recalls involving this device
No recalls on record reference this clearance.