FDA 510(k) Application Details - K162525

Device Classification Name Prosthesis, Nail

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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
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Contact FATMA GULRU ERDOGAN
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Regulation Number 000.0000

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Classification Product Code MQZ
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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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