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510(k) K990440

GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE by Gentell — Product Code MGQ

K990440 is an FDA 510(k) premarket notification submitted by Gentell for the device "GENTELL HYDROGEL SPRAY GEL, APPLIGARD SQUEEZE". The FDA issued a decision of Substantially Equivalent on Aug 12, 1999. The device falls under product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), a Class U device.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 12, 1999
Date Received
Feb 11, 1999
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
Review Panel
SU
Submission Type
510(k)

Other clearances for product code MGQ

  • K171879 — HylaGuard Moisturizing Cream (Oct 16, 2017)
  • K083024 — HYLATOPIC EMOLLIENT FOAM (Mar 27, 2009)
  • K041342 — IMPRUV A.I. CREAM WOUND AND SKIN EMULSION (Jul 19, 2005)
  • K041268 — SILVERSITE OR CALGITROL (Sep 20, 2004)
  • K040019 — SILVERSEAL (Jul 23, 2004)
  • K040517 — TENDERWET ACTIVE (Mar 25, 2004)
  • K022587 — MEDTRADE PRODUCT'S ANTISEPTIC BARRIER HYDROGEL DRESSINGS (Aug 22, 2003)
  • K024367 — SINCLAIR WOUND AND SKIN EMULSION (Jul 28, 2003)
  • K024054 — XYLOS XCELL ANTIMICROBIAL DRESSING (Mar 7, 2003)
  • K022584 — CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING (Dec 30, 2002)

FDA data resources

Source: FDA 510(k) database entry for K990440. Report a data issue: hello@regdatalab.com.