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510(k) K935796

HYDRODERM BREATHABLE TRANSPARENT DRESSING by Wilshire Medical Products — Product Code MGP

K935796 is an FDA 510(k) premarket notification submitted by Wilshire Medical Products for the device "HYDRODERM BREATHABLE TRANSPARENT DRESSING". The FDA issued a decision of Substantially Equivalent on February 2, 1994. The device falls under product code MGP (Dressing, Wound And Burn, Occlusive), a Class U device. Wilshire Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1994
Date Received
December 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Occlusive
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Wilshire Medical Products

  • K946030 — DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING (February 27, 1995)
  • K946031 — DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING (February 27, 1995)
  • K944333 — HYDRODERM GEL WOUND DRESSING (November 10, 1994)
  • K941216 — HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING (May 20, 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)

Other clearances for product code MGP

  • K012995 — COLLATEK SHEET (October 25, 2001)
  • K012997 — COLLATEK FOAM (October 25, 2001)
  • K001508 — LASERSKIN DRESSING (July 25, 2001)
  • K990079 — FASTSEAL CHEST WOUND DRESSING (December 23, 1999)
  • K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING (October 14, 1999)
  • K992302 — DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (September 14, 1999)
  • K992005 — GILTECH PLUS TRANSPARENT DRESSING (September 3, 1999)
  • K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (May 27, 1999)
  • K990438 — DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSI (March 25, 1999)
  • K984371 — MEPITEL NON ADHERENT SILICONE DRESSING (March 3, 1999)

FDA data resources