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510(k) K033732

MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450 by Medtrade Products , Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2004
Date Received
November 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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  • K093519 — MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET (January 14, 2010)
  • K091795 — MEDTRADE PRODUCTS CELOX TRAUMA GAUZE (November 20, 2009)
  • K090780 — MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE (November 20, 2009)

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