FDA 510(k) Application Details - K012539

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K012539
Device Name Laparoscope, General & Plastic Surgery
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact CHESTER MCCOY
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 08/07/2001
Decision Date 09/06/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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