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510(k) K861558

APLICARE SKIN PROTECTANT SWABSTICK by Aplicare, Inc. — Product Code NEC

K861558 is an FDA 510(k) premarket notification submitted by Aplicare, Inc. for the device "APLICARE SKIN PROTECTANT SWABSTICK". The FDA issued a decision of Substantially Equivalent on June 4, 1986. The device falls under product code NEC (Bandage, Liquid, Skin Protectant), a Class I device regulated under 21 CFR 880.5090. Aplicare, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1986
Date Received
April 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Aplicare, Inc.

  • K923299 — APLICARE ONE COMPUND BENZION TINCTURE SWABSTICK (January 18, 1994)
  • 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)
  • K833185 — ACETONE ALCOHOL PREP PAD (October 31, 1983)
  • K833183 — APLICARE ONE ACETONE ALCOHOL SWABSTICK (October 31, 1983)
  • K833184 — APLICARE THREE ALCOHOL SWABSTICKS (October 27, 1983)
  • K833182 — APLICARE ALCOHOL PREP PAD (October 27, 1983)

Other clearances for product code NEC

  • K972081 — SUPERSKIN (December 17, 1997)
  • K861557 — APLICARE SKIN PROTECTANT PREP PAD (July 11, 1986)

FDA data resources