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510(k) K030901

MEDTRADE PRODICT'S SOOTHING GEL PATCH by Medtrade Products , Ltd. — Product Code NTC

K030901 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "MEDTRADE PRODICT'S SOOTHING GEL PATCH". The FDA issued a decision of Substantially Equivalent on November 26, 2004. The device falls under product code NTC (Nursing Pad, Hydrogel), a Class I device regulated under 21 CFR 880.5630. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2004
Date Received
March 24, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nursing Pad, Hydrogel
Device Class
Class I
Regulation Number
880.5630
Review Panel
HO
Submission Type

Other clearances by Medtrade Products , Ltd.

  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K161274 — Bondiloxs Topical Hemostatic Granules (January 18, 2017)
  • K132333 — BONDILOXS TOPICAL HEMOSTATIC DRESSING (June 25, 2014)
  • K120930 — CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM (October 26, 2012)
  • K113560 — CELOX GAUZE PRO (August 1, 2012)
  • K110386 — CELOX RAPID GAUZE (May 10, 2011)
  • K102965 — CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TR (December 8, 2010)
  • K093519 — MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET (January 14, 2010)
  • K090780 — MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE (November 20, 2009)
  • K091795 — MEDTRADE PRODUCTS CELOX TRAUMA GAUZE (November 20, 2009)

FDA data resources