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510(k) K932263

SOLOSITE DERMAL WOUND GEL by Smith & Nephew United, Inc. — Product Code MGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1993
Date Received
April 20, 1993
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 Smith & Nephew United, Inc.

  • K963096 — ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING (October 25, 1996)
  • K961775 — PROFORE FOUR-LAYER BANDAGE SYSTEM KIT (July 16, 1996)
  • K945330 — ALLEVYN ADHESIVE (February 9, 1995)
  • K943619 — CAVI-CARE CONFORMING FOAM DRESSING (August 19, 1994)
  • K942748 — INTRASITE (June 29, 1994)
  • K935705 — ALLEVYN ISLAND WOUND DRESSING (February 15, 1994)
  • K935803 — CICA-CARE SILICONE GEL SHEET (February 3, 1994)
  • K926508 — INTRASITE GEL (July 13, 1993)
  • K922897 — STRAPPAL (September 15, 1992)
  • K914147 — ALLEVLYN WOUND DRESSING, MODIFICATION (February 3, 1992)

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  • 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)