FDA 510(k) Application Details - K010220

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K010220
Device Name Laparoscope, General & Plastic Surgery
Applicant INSTRUMENTS MEDICAUX G.B., INC.
REGULATORY AFFAIRS
411 BELVEDERE SUD
SHERBROOKE, QUEBEC CA
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Contact MARTIN PAQUETTE
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 01/24/2001
Decision Date 04/09/2001
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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