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510(k) K802385

CUSTOM DRESSING TRAY-WET TO DRY/MASS. by American Medical Disposable, Inc. — Product Code FPX

K802385 is an FDA 510(k) premarket notification submitted by American Medical Disposable, Inc. for the device "CUSTOM DRESSING TRAY-WET TO DRY/MASS.". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code FPX (Strip, Adhesive, Closure, Skin), a Class I device regulated under 21 CFR 880.5240. American Medical Disposable, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 2, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Strip, Adhesive, Closure, Skin
Device Class
Class I
Regulation Number
880.5240
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)
  • K833731 — BREATHABLE OVERWRAY BANDAGE NON-ELAS (January 27, 1984)
  • K833730 — NON ADHERENT BANDAGE/SHEET (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)
  • K830201 — POLYESTER X-RAY DETECTABLE STRUNG-SPONGE (February 23, 1983)
  • K830202 — COTTON BALLS, X-RAY OPAQUED STRUNG & NON (February 23, 1983)
  • K803116 — HEAVY DRAINAGE PACK (January 28, 1981)

Other clearances for product code FPX

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • K952947 — DELPORE SKIN CLOSURE (July 24, 1995)
  • K952702 — DERMA SEAL (June 28, 1995)
  • K946321 — BIOSTRIP STERILE WOUND CLOSURE STRIP (January 12, 1995)
  • K931005 — DUKAL SKIN CLOSURE STRIP (July 14, 1993)
  • K921775 — SPYROFLEX WOUND CLOSURES (May 19, 1992)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K894205 — TECNOL SILK STRIP (July 25, 1989)
  • K874813 — OMED WOUND CLOSURE STRIPS (January 29, 1988)
  • K840945 — SKIN CLOSURE (October 31, 1984)

FDA data resources