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510(k) K902009

ELANTEC'S SURGICAL TAPE REMOVER by Elantec, Inc. — Product Code KOX

K902009 is an FDA 510(k) premarket notification submitted by Elantec, Inc. for the device "ELANTEC'S SURGICAL TAPE REMOVER". The FDA issued a decision of Substantially Equivalent on August 29, 1990. The device falls under product code KOX (Solvent, Adhesive Tape), a Class I device regulated under 21 CFR 878.4730.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1990
Date Received
May 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solvent, Adhesive Tape
Device Class
Class I
Regulation Number
878.4730
Review Panel
SU
Submission Type

Other clearances for product code KOX

  • K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
  • K931933 — CHAD LABS ADHESIVE BANDAGE REMOVER (July 8, 1993)
  • K924976 — ALLKARE(TM) ADHESIVE REMOVER WIPE (April 20, 1993)
  • K924571 — MEDI-SOL (April 6, 1993)
  • K925618 — 3M REMOVER LOTION PRODUCT NUMBER 86XX (March 31, 1993)
  • K923351 — SKIN SUPPORT PREP PAD (September 14, 1992)
  • K915150 — REMOVE ADHESIVE REMOVER (January 9, 1992)
  • K895293 — KEMI LABS - ADHESIVE BANDAGE REMOVER (February 9, 1990)
  • K893603 — REMOVE ADHESIVE REMOVER (July 14, 1989)
  • K881359 — DECALCIFYING SOLUTION II (April 19, 1988)

FDA data resources