FDA 510(k) Application Details - K973795

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K973795
Device Name Laparoscope, General & Plastic Surgery
Applicant SOPRO
PLACE ST. CHRISTOPHE
LES ACCATES-LA VALENTINE
MARSEILLE 13011 FR
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Contact PIERRE MONTILLOT
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 10/06/1997
Decision Date 01/02/1998
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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