510(k) K121170

RESIN 11 by Respinnovation Sas — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2012
Date Received
April 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type