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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 K940398
Device Name AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II
Applicant
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Applicant Contact DEBORAH ROCKAFELLOW
Correspondent
United States Surgical, A Division of Tyco Healthc
150 Glover Ave.
Norwalk,  CT  06856
Correspondent Contact DEBORAH ROCKAFELLOW
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/27/1994
Decision Date 04/07/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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