FDA 510(k) Application Details - K121701

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K121701
Device Name Laparoscope, General & Plastic Surgery
Applicant OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY, PA 18034-0610 US
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Contact KATHY ANDERSON
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 06/08/2012
Decision Date 06/29/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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