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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Tissue Approximation Device
510(k) Number K960011
Device Name ENDOSCOPIC NEEDLE DRIVER
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact VICTOR CLAVELLI
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact VICTOR CLAVELLI
Regulation Number876.1500
Classification Product Code
OCW  
Date Received01/02/1996
Decision Date 02/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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