510(k) K963293
- Device
- AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
- Applicant
- AUGUSTINE MEDICAL, INC.
- 510(k) number
- K963293
- Product code
- MSA
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1997-03-28
- Date received
- 1996-08-21
- Regulation
- 510(k) Premarket Notification
- Classification name
- Dressing, Wound And Burn, Occlusive, Heated
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SCOTT D AUGUSTINE
- Address
- 10393 W. 70th St. Eden Prairie MN US 55344 55344
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MSA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020077 | MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX | Augustine Medical, Inc. | 2002-01-31 |
Legacy Summary#
summary
FDA Review#
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