FDA 510(k) Application Details - K960011

Device Classification Name Endoscopic Tissue Approximation Device

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510(K) Number K960011
Device Name Endoscopic Tissue Approximation Device
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact VICTOR CLAVELLI
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Regulation Number 876.1500

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Classification Product Code OCW
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Date Received 01/02/1996
Decision Date 02/21/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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