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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter And Tip, Suction
510(k) Number K942061
Device Name DISPOSABLE SUCTION PROBE
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 Number880.6740
Classification Product Code
JOL  
Date Received04/29/1994
Decision Date 05/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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