FDA 510(k) Application Details - K973232

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K973232
Device Name Laparoscope, General & Plastic Surgery
Applicant OLYMPUS WINTER & IBE GMBH
KUEHNSTRASSE 61
HAMBURG 70 2000 DE
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Contact SUBHASH R PATEL
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 08/28/1997
Decision Date 11/21/1997
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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