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510(k) K963293

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

Clearance Details

Decision
SN ()
Decision Date
March 28, 1997
Date Received
August 21, 1996
Clearance Type
Traditional
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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  • K960167 — SYSTEM, THERMAL REGULATING 74-DWJ (June 17, 1996)
  • K954446 — AUGUSTINE INTUBATION GUIDE (December 29, 1995)
  • K952864 — BAIR HUGGER MODEL 655 BLANKET (September 12, 1995)
  • K950416 — BAIR HUGGER MODEL 600 UNIT, BLANKETS (August 29, 1995)

Other clearances for product code MSA

  • K020077 — MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX (January 31, 2002)