MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX— 510(k) K020077
Substantially EquivalentAugustine Medical, Inc.
FDA 510(k) clearance K020077 for MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX, Substantially Equivalent on 2002-01-31. 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
- Clearance type
- Special
- Location
- Eden Prairie, MN, US
Recent devices under product code MSA
view allMore clearances from Augustine Medical, Inc.
view all- K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
- K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
- K973741 — BAIR HUGGER BLOOD/FLUID WARMER
- K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET
- K963672 — MODEL 90022 ROLLING STAND
Data sourced from openFDA. This site is unofficial and independent of the FDA.