FDA 510(k) Application Details - K961611

Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered

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510(K) Number K961611
Device Name Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant OLYMPUS AMERICA, INC.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
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Contact BARRY E SANDS
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Regulation Number 876.1500

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Classification Product Code OCZ
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Date Received 04/25/1996
Decision Date 07/18/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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