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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 K921597
Device Name CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
Applicant
Haemotronic, Inc.
45 Kulick Rd.
Fairfield,  NJ  07004
Applicant Contact WILLER GHELFI
Correspondent
Haemotronic, Inc.
45 Kulick Rd.
Fairfield,  NJ  07004
Correspondent Contact WILLER GHELFI
Regulation Number876.5820
Classification Product Code
FJK  
Date Received04/03/1992
Decision Date 02/24/1995
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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