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510(k) K951862

A GEL WOUND DRESSING by Polymedica Industries, Inc. — Product Code MGQ

K951862 is an FDA 510(k) premarket notification submitted by Polymedica Industries, Inc. for the device "A GEL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on July 12, 1995. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Polymedica Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1995
Date Received
April 21, 1995
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 Polymedica Industries, Inc.

  • K964398 — SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED (October 24, 1997)
  • K971045 — BASIS FLEXIBLE TIP DIGITAL THERMOMETER (May 2, 1997)
  • K964701 — MITRAFLEX PIGMENTED WOUND DRESSING (February 7, 1997)
  • K963623 — SPYROFLEX PIGMENTED WOUND DRESSING (October 25, 1996)
  • K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER (September 12, 1996)
  • K955383 — SPYROCOLLOID WOUND DRESSING (December 13, 1995)
  • K953885 — SPYROFLEX SKIN PROTECTOR (November 29, 1995)
  • K952756 — MEDI-AID BASAL THERMOMETER (September 25, 1995)
  • K952159 — BASIS DIGITAL THERMOMETER (September 22, 1995)
  • K953618 — SPYROFLEX WOUND DRESSING (August 21, 1995)

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