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FDA 510(k) Application Details - K162525
Device Classification Name
Prosthesis, Nail
More FDA Info for this Device
510(K) Number
K162525
Device Name
Prosthesis, Nail
Applicant
BEGUM SAGLIK HIZMETLERI TIBBI MALZEMELER DANISMANLIK LSTI
RESIT GALIP CAD. NO: 124/10 GOP
CANKAYA 06700 TR
Other 510(k) Applications for this Company
Contact
FATMA GULRU ERDOGAN
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MQZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2016
Decision Date
04/25/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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