510(k) K033587

SILVERSEAL by Noble Fiber Technologies — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2004
Date Received
November 13, 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