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510(k) K934790

SEPP ADHESIVE REMOVER by Medi-Flex Hospital Products, Inc. — Product Code KOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1994
Date Received
October 5, 1993
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 by Medi-Flex Hospital Products, Inc.

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  • K962740 — DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 (September 6, 1996)
  • K952201 — PORT-A-CATH ACCESS KIT (October 4, 1995)
  • K952416 — TRACHEOSTOMY CARE KIT (August 9, 1995)
  • K952256 — PICC LINE KIT (July 31, 1995)
  • K952007 — ADHEROL SEPP APPLICATOR (June 8, 1995)
  • K923516 — COMPOUND BENZOIN TINCTURE USP SEPP (January 25, 1994)
  • K920399 — COMPOUND BENZOIN TINCTURE USP FREPP (January 25, 1994)
  • K930196 — CEPTI-SEAL I.V. PREP KIT (July 2, 1993)
  • K921347 — CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER (January 8, 1993)

Other clearances for product code KOX

  • 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)
  • 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)