FDA 510(k) Application Details - K983561

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K983561
Device Name Laparoscope, General & Plastic Surgery
Applicant FUJINON, INC.
399 PARK AVE.
NEW YORK, NY 10022-4689 US
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Contact GARY A ADLER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 10/13/1998
Decision Date 12/16/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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