510(k) K003979

MEDTRADE PRODUCTS SILICON SCAR MANAGEMENT PAD by Medtrade Products , Ltd. — Product Code MDA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2001
Date Received
December 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone, For Scar Management
Device Class
Class I
Regulation Number
878.4025
Review Panel
SU
Submission Type