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510(k) K803114

HYPERALIMENTATION DRESSING CHANGE TRAY by American Medical Disposable, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1980
Date Received
December 10, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by American Medical Disposable, Inc.

  • K833735 — AN ODOR ABSORBENT BANDAGE (April 23, 1984)
  • K833734 — NEUROLOGICAL SPONGE ON PLASTIC STICK (April 23, 1984)
  • K833730 — NON ADHERENT BANDAGE/SHEET (January 27, 1984)
  • K833731 — BREATHABLE OVERWRAY BANDAGE NON-ELAS (January 27, 1984)
  • K833729 — ELASTIC BREATHABLE OVER-WRAP BANDAGE (December 30, 1983)
  • K833733 — NON - ADHERENT BANDAGE (December 27, 1983)
  • K833732 — NON WETTING UNDERCAST PADDING (December 12, 1983)
  • K830202 — COTTON BALLS, X-RAY OPAQUED STRUNG & NON (February 23, 1983)
  • K830201 — POLYESTER X-RAY DETECTABLE STRUNG-SPONGE (February 23, 1983)
  • K803116 — HEAVY DRAINAGE PACK (January 28, 1981)

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