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510(k) K020077

MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX by Augustine Medical, Inc. — Product Code MSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2002
Date Received
January 9, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive, Heated
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type

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Other clearances for product code MSA

  • K963293 — AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (March 28, 1997)