FDA 510(k) Application Details - K963919

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K963919
Device Name Laparoscope, General & Plastic Surgery
Applicant LSI SOLUTIONS
2144 BRIGHTON-HENRIETTA TOWN
LINE RD.
ROCHESTER, NY 14623 US
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Contact JUDE S SAUER
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 09/30/1996
Decision Date 01/08/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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