FDA 510(k) Application Details - K972056

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K972056
Device Name Laparoscope, General & Plastic Surgery
Applicant LASER-OPTIK-SYSTEME GMBH & CO. KG
AM SAGEWERK 11
MAINZ 55124 DE
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Contact MARC STRELOW
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 06/02/1997
Decision Date 07/30/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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