510(k) K020077
- Device
- MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
- Applicant
- Augustine Medical, Inc.
- 510(k) number
- K020077
- Product code
- MSA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-01-31
- Date received
- 2002-01-09
- Regulation
- 878.4020
- Classification name
- Dressing, Wound And Burn, Occlusive, Heated
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- SCOTT D AUGUSTINE
- Address
- 10393 W. 70th St. Eden Prairie MN US 55344 55344
Source Documents#
Other 510(k) Records For Product Code MSA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963293 | AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX | Augustine Medical, Inc. | 1997-03-28 |