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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K905426
Device Name AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
Original Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 glover ave.
norwalk,  CT  06856
Original Contact steve reitzler
Regulation Number884.1720
Classification Product Code
HET  
Date Received12/04/1990
Decision Date 02/11/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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