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510(k) K020077

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

K020077 is an FDA 510(k) premarket notification submitted by Augustine Medical, Inc. for the device "MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX". The FDA issued a decision of Substantially Equivalent on January 31, 2002. The device falls under product code MSA (Dressing, Wound And Burn, Occlusive, Heated), a Class I device regulated under 21 CFR 878.4020. Augustine Medical, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Augustine Medical, Inc.

  • K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM (July 9, 2002)
  • K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MO (September 6, 2000)
  • K973741 — BAIR HUGGER BLOOD/FLUID WARMER (April 30, 1998)
  • K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET (June 26, 1997)
  • K963293 — AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX (March 28, 1997)
  • K963672 — MODEL 90022 ROLLING STAND (January 6, 1997)
  • 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

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

FDA data resources