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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K992288
Device Name AUTO SUTURE* SOFT THORACOPORT** OBTURATOR AND SLEEVE
Applicant
Tyco Intl. (Us), Inc.
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact CHRISTOPHER A GRAHAM
Correspondent
Tyco Intl. (Us), Inc.
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact CHRISTOPHER A GRAHAM
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/07/1999
Decision Date 07/30/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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