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510(k) K924571

MEDI-SOL by Orange-Sol, Inc. — Product Code KOX

K924571 is an FDA 510(k) premarket notification submitted by Orange-Sol, Inc. for the device "MEDI-SOL". The FDA issued a decision of Substantially Equivalent on April 6, 1993. 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
April 6, 1993
Date Received
September 10, 1992
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)
  • 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)
  • K902009 — ELANTEC'S SURGICAL TAPE REMOVER (August 29, 1990)
  • 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