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510(k) K941216

HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING by Wilshire Medical Products — Product Code KMF

K941216 is an FDA 510(k) premarket notification submitted by Wilshire Medical Products for the device "HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING". The FDA issued a decision of SN on May 20, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Wilshire Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
May 20, 1994
Date Received
March 14, 1994
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 Wilshire Medical Products

  • K946031 — DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING (February 27, 1995)
  • K946030 — DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING (February 27, 1995)
  • K944333 — HYDRODERM GEL WOUND DRESSING (November 10, 1994)
  • K941149 — DERMAASSIST HYDROCOLLOID DRESSING (May 20, 1994)
  • K941005 — DERMASSIST(TM) XEROFORM PETROLATUM DRESSING (April 14, 1994)
  • K940044 — DERMASSIST WET DRESSING, SALINE (March 3, 1994)
  • K936234 — DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING (March 3, 1994)
  • K936230 — DERMASSIST PETROLATUM GAUZE,USP (March 3, 1994)
  • K940076 — DERMASSIST WET DRESSING, WATER (March 3, 1994)
  • K935796 — HYDRODERM BREATHABLE TRANSPARENT DRESSING (February 2, 1994)

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