FDA 510(k) Application Details - K093194

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K093194
Device Name Laparoscope, General & Plastic Surgery
Applicant MGB ENDOSKOPISCHE GERATE GMBH (BERLIN)
SCHWARZSCHILDSTRASSE 6
BERLIN D-12489 DE
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Contact PATRICK GAENSICKE
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 10/09/2009
Decision Date 03/03/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
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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