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FDA 510(k) Application Details - K152734
Device Classification Name
Rongeur, Manual
More FDA Info for this Device
510(K) Number
K152734
Device Name
Rongeur, Manual
Applicant
VITALITEC MEDIZINTECHNIK GMBH
STEIGAECKER 20
BALGHEIM (BADEN-WURTTEM BERG) 78582 DE
Other 510(k) Applications for this Company
Contact
LYNETTE HOWARD
Other 510(k) Applications for this Contact
Regulation Number
882.4840
More FDA Info for this Regulation Number
Classification Product Code
HAE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2015
Decision Date
06/18/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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