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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 K821138
Device Name TS-180 SERIES TUBING SET
Applicant
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
ROYAL & ROSS ROADS
KING OF PRUSSIA,  PA  19406 -
Applicant Contact JAMES K MCCRACKEN
Correspondent
EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
ROYAL & ROSS ROADS
KING OF PRUSSIA,  PA  19406 -
Correspondent Contact JAMES K MCCRACKEN
Regulation Number876.5820
Classification Product Code
FJK  
Date Received04/21/1982
Decision Date 05/10/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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