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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, dialysate delivery, single patient
510(k) Number K811591
Device Name B-D DRAKE WILLOCK #7000 SERIES ULTRAF
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5820
Classification Product Code
FKP  
Date Received06/08/1981
Decision Date 07/10/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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