FDA 510(k) Application Details - K992353

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K992353
Device Name Laparoscope, General & Plastic Surgery
Applicant ORIGIN MEDSYSTEMS, INC.
1525 O'BRIEN DR.
MENLO PARK, CA 94025 US
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Contact LORI E ADELS
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 07/14/1999
Decision Date 07/30/1999
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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