MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
FDA 510(k) clearance K020077 · decided 2002-01-31
Clearance details
- K-number
- K020077
- Device name
- MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
- Applicant
- Augustine Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-09
- Decision date
- 2002-01-31
- Days to decision
- 22 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Augustine Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (K963293) | Augustine Medical, Inc. | 1997-03-28 |
Recalls involving this device
No recalls on record reference this clearance.