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510(k) K962160

MPM HYDROGEL DRESSING (NON-STERILE) by Mpm Medical., Inc. — Product Code MGQ

K962160 is an FDA 510(k) premarket notification submitted by Mpm Medical., Inc. for the device "MPM HYDROGEL DRESSING (NON-STERILE)". The FDA issued a decision of Substantially Equivalent on June 26, 1996. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Mpm Medical., Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1996
Date Received
June 4, 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 Mpm Medical., Inc.

  • K060340 — ORAMAGIC PLUS ORAL WOUND RINSE (May 10, 2006)
  • K024180 — ORAMAGICRX ORAL WOUND RINSE (March 14, 2003)
  • K020540 — REGENECARE WOUND GEL (November 1, 2002)
  • K992074 — MPM REGENECARE WOUND GEL (December 23, 1999)
  • K952276 — MPM HYDROGEL DRESSING (June 30, 1995)
  • K942798 — MPM HYDROGEL (July 11, 1994)
  • K930560 — MPM HYDROGEL SATURATED DRESSING (July 8, 1993)
  • K926044 — MPM WET DRESSING (SALINE) (April 8, 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