510(k) K040042

MEDISIL SILICONE SHEETING by Medisil Corporation — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2004
Date Received
January 12, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone Block
Device Class
Class II
Regulation Number
874.3620
Review Panel
SU
Submission Type