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510(k) K083024

HYLATOPIC EMOLLIENT FOAM by Collegium Pharmaceutical Incorporated — Product Code MGQ

K083024 is an FDA 510(k) premarket notification submitted by Collegium Pharmaceutical Incorporated for the device "HYLATOPIC EMOLLIENT FOAM". The FDA issued a decision of Substantially Equivalent on March 27, 2009. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device. Collegium Pharmaceutical Incorporated has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2009
Date Received
October 9, 2008
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 Collegium Pharmaceutical Incorporated

  • K093320 — DRYODINE CADEXOMER-IODINE GEL (June 18, 2010)
  • K093051 — HYLATOPIC PLUS EMOLLIENT FOAM (December 7, 2009)

Other clearances for product code MGQ

  • K171879 — HylaGuard Moisturizing Cream (October 16, 2017)
  • 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)
  • K022995 — COLLATEK HYDROGEL (December 2, 2002)

FDA data resources