510(k) K033732

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

K033732 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450". The FDA issued a decision of Substantially Equivalent on December 1, 2004. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.

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