AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX— 510(k) K963293
Substantially Equivalent for Some IndicationsAugustine Medical, Inc.
FDA 510(k) clearance K963293 for AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX, Substantially Equivalent for Some Indications on 1997-03-28. Applicant: Augustine Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Augustine Medical, Inc.
- Product code
- Code MSA
- Device class
- Class 1
- Regulation
- 21 CFR 878.4020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.