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510(k) K911550

2ND SKIN MOIST BURN PADS WITH ALOE by Spenco Medical Corp. — Product Code MGQ

K911550 is an FDA 510(k) premarket notification submitted by Spenco Medical Corp. for the device "2ND SKIN MOIST BURN PADS WITH ALOE". The FDA issued a decision of Substantially Equivalent on September 6, 1991. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Spenco Medical Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1991
Date Received
April 8, 1991
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 Spenco Medical Corp.

  • K981902 — SPENCO SILICONE GEL SHEET (June 25, 1998)
  • K922228 — 2ND SKIN STERILE ADHESIVE STRIP (December 11, 1992)
  • K910927 — SPENCIO SKIN GUARD KIT (June 3, 1991)
  • K896533 — SPENCO BREAST FORMS (December 13, 1989)
  • K894898 — 2ND SKIN NON-STICK MOIST BURN PADS (August 23, 1989)
  • K820906 — SPENCO CRYOPRESS (May 13, 1982)
  • K811184 — SPENCO DERMAL PADS (May 20, 1981)
  • K791726 — HYDROGEL-PREP (November 20, 1979)
  • K791162 — GELSKIN (September 4, 1979)

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