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510(k) K852408

EXTRA LARGE ADHESIVE STRIPS by American White Cross, Inc. — Product Code KGX

K852408 is an FDA 510(k) premarket notification submitted by American White Cross, Inc. for the device "EXTRA LARGE ADHESIVE STRIPS". The FDA issued a decision of Substantially Equivalent on July 29, 1985. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. American White Cross, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1985
Date Received
June 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by American White Cross, Inc.

  • K964614 — ULTRAFERA WOUND DRESSING (February 6, 1997)
  • K962400 — AIR MAX EXTERNAL NASAL DILATOR STRIP (September 9, 1996)
  • K894802 — AWC BUTTERFLY WOUND CLOSURES (January 31, 1990)
  • K854809 — WHITE CROSS STERILE PAD 4IN. X 4IN. (January 13, 1986)
  • K853558 — DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ (September 5, 1985)
  • K853334 — NON-ADHERA ADHESIVE PAD 3X4 (August 21, 1985)
  • K852412 — NON-ADHERENT PAD (July 29, 1985)
  • K852462 — TRICOT ADHESIVE BANDAGE (July 26, 1985)
  • K850595 — 3 X 4 NON-ADHERENT PAD (March 11, 1985)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources