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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Source, Fiberoptic, Routine
510(k) Number K934531
Device Name AUTO SUTURE DISPOSABLE LIGHT CABLE
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Applicant Contact PAUL D SMOLENSKI
Correspondent
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK,  CT  06856
Correspondent Contact PAUL D SMOLENSKI
Regulation Number876.1500
Classification Product Code
FCW  
Date Received09/20/1993
Decision Date 05/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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