FDA 510(k) Application Details - K950712

Device Classification Name Endoscope, Rigid

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510(K) Number K950712
Device Name Endoscope, Rigid
Applicant LASER-OPTIK-SYSTEME GMBH & CO. KG
AM SAGEWERK 11
MAINZ 55124 DE
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Regulation Number 876.1500

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Classification Product Code GCM
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Date Received 02/14/1995
Decision Date 05/14/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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