The following data is part of a premarket notification filed by Augustine Medical, Inc. with the FDA for Augustine Medical Wound Care System Model 68xxx.
| Device ID | K963293 |
| 510k Number | K963293 |
| Device Name: | AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX |
| Classification | Dressing, Wound And Burn, Occlusive, Heated |
| Applicant | AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | Scott D Augustine |
| Correspondent | Scott D Augustine AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | MSA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-21 |
| Decision Date | 1997-03-28 |
| Summary: | summary |