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510(k) K920399

COMPOUND BENZOIN TINCTURE USP FREPP by Medi-Flex Hospital Products, Inc. — Product Code KMF

K920399 is an FDA 510(k) premarket notification submitted by Medi-Flex Hospital Products, Inc. for the device "COMPOUND BENZOIN TINCTURE USP FREPP". The FDA issued a decision of Substantially Equivalent on January 25, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Medi-Flex Hospital Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1994
Date Received
January 30, 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 Medi-Flex Hospital Products, Inc.

  • K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH (May 9, 1997)
  • 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)
  • K934790 — SEPP ADHESIVE REMOVER (March 11, 1994)
  • K923516 — COMPOUND BENZOIN TINCTURE USP SEPP (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 KMF

  • K241916 — TearRepair Liquid Skin Protectant (September 27, 2024)
  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K171148 — Aleo BME Liquid Bandage (January 12, 2018)
  • K153571 — Cavilon Advanced High Endurance Skin Protectant (August 23, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)
  • K131384 — KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (August 7, 2014)
  • K133443 — MARATHON NO STING LIQUID SKIN PROTECTANT (July 10, 2014)
  • K120059 — LIQUID BANDAGE (May 17, 2012)
  • K092712 — SKIN BARRIER FILM (February 23, 2010)
  • K083087 — ECOCEL (August 7, 2009)

FDA data resources