510(k) K121436

DAS MEDICAL EQUIPMENT DRAPES by Das Medical, LLC — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2013
Date Received
May 15, 2012
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