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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 K854271
Device Name ASA BLOOD TUBING LINES
Applicant
ORGANON TEKNIKA CORP.
5300 SOUTH PORTLAND AVE.
OKLAHOMA CITY,  OK  73119
Applicant Contact MARING ROBERTS
Correspondent
ORGANON TEKNIKA CORP.
5300 SOUTH PORTLAND AVE.
OKLAHOMA CITY,  OK  73119
Correspondent Contact MARING ROBERTS
Regulation Number876.5820
Classification Product Code
FJK  
Date Received10/23/1985
Decision Date 11/05/1985
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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