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510(k) K962439

DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) by Richard Hamer Assoc., Inc. — Product Code MGQ

K962439 is an FDA 510(k) premarket notification submitted by Richard Hamer Assoc., Inc. for the device "DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)". The FDA issued a decision of Substantially Equivalent on September 3, 1996. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Richard Hamer Assoc., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1996
Date Received
June 24, 1996
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 Richard Hamer Assoc., Inc.

  • K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING (July 31, 1995)
  • K950934 — MPM HYDROGEL DRESSING (May 16, 1995)
  • K951327 — COMFEEL PLUS CONTOUR DRESSING (April 28, 1995)
  • K942283 — COMFEEL PLUS TRANSPARENT DRESSING (July 29, 1994)
  • K942573 — COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH (July 18, 1994)
  • K941263 — COMFEEL PLUS WOUND DRESSING (May 10, 1994)
  • K934839 — MESALT STERILE DRESSING (December 22, 1993)

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