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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
510(k) Number K950247
Device Name TS 564/PF
Applicant
Bressler, Amery & Ross
P.O. Box 1980
Morristown,  NJ  07962
Applicant Contact ERIC J NEMETH
Correspondent
Bressler, Amery & Ross
P.O. Box 1980
Morristown,  NJ  07962
Correspondent Contact ERIC J NEMETH
Regulation Number876.5820
Classification Product Code
FJK  
Date Received01/20/1995
Decision Date 11/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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