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510(k) K946030

DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING by Wilshire Medical Products — Product Code MGQ

K946030 is an FDA 510(k) premarket notification submitted by Wilshire Medical Products for the device "DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING". The FDA issued a decision of Substantially Equivalent on February 27, 1995. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), 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 27, 1995
Date Received
December 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Wilshire Medical Products

  • K946031 — DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING (February 27, 1995)
  • K944333 — HYDRODERM GEL WOUND DRESSING (November 10, 1994)
  • K941149 — DERMAASSIST HYDROCOLLOID DRESSING (May 20, 1994)
  • K941216 — HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID 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)
  • K940076 — DERMASSIST WET DRESSING, WATER (March 3, 1994)
  • K936230 — DERMASSIST PETROLATUM GAUZE,USP (March 3, 1994)
  • K935796 — HYDRODERM BREATHABLE TRANSPARENT DRESSING (February 2, 1994)

Other clearances for product code MGQ

  • K171879 — HylaGuard Moisturizing Cream (October 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (March 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (July 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (September 20, 2004)
  • K040019 — SILVERSEAL (July 23, 2004)
  • K040517 — TENDERWET ACTIVE (March 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (August 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (July 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (March 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (December 30, 2002)

FDA data resources