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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K893707
Device Name AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT
Applicant
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact CURTIS RAYMOND
Correspondent
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact CURTIS RAYMOND
Regulation Number870.1390
Classification Product Code
DRC  
Date Received05/18/1989
Decision Date 06/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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