FDA 510(k) Application Details - K993688

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K993688
Device Name Laparoscope, General & Plastic Surgery
Applicant NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
10801 NATIONAL BLVD., #603
LOS ANGELES, CA 90064 US
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Contact GAYLE M BUTLER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 11/01/1999
Decision Date 12/06/1999
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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