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510(k) K121170

RESIN 11 by Respinnovation Sas — Product Code BYI

K121170 is an FDA 510(k) premarket notification submitted by Respinnovation Sas for the device "RESIN 11". The FDA issued a decision of Substantially Equivalent on July 13, 2012. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665.

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

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FDA data resources