510(k) K060046

DERMASTREAM by Enzysurge , Ltd. — Product Code NAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2006
Date Received
January 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Occlusive
Device Class
Class I
Regulation Number
878.4020
Review Panel
SU
Submission Type