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510(k) K923299

APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK by Aplicare, Inc. — Product Code KMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1994
Date Received
July 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type

Other clearances by Aplicare, Inc.

  • K895039 — STERILE SALINE - FOR SUCTION CATHETER LUBRICATION (October 3, 1989)
  • K873563 — APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY (November 23, 1987)
  • K861557 — APLICARE SKIN PROTECTANT PREP PAD (July 11, 1986)
  • K861558 — APLICARE SKIN PROTECTANT SWABSTICK (June 4, 1986)
  • K833183 — APLICARE ONE ACETONE ALCOHOL SWABSTICK (October 31, 1983)
  • K833185 — ACETONE ALCOHOL PREP PAD (October 31, 1983)
  • K833184 — APLICARE THREE ALCOHOL SWABSTICKS (October 27, 1983)
  • K833182 — APLICARE ALCOHOL PREP PAD (October 27, 1983)

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