510(k) K140195

SURGICAL DRAPE by Griffith-Lucas, LLC — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2014
Date Received
January 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type