510(k) K152734

Kerrison Rongeurs by Vitalitec Medizintechnik GmbH — Product Code HAE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2016
Date Received
September 22, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rongeur, Manual
Device Class
Class II
Regulation Number
882.4840
Review Panel
NE
Submission Type