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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K002954
Device Name RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
Applicant
RUDOLF RIESTER GMBH & CO. KG
BRUCKSTRASSE 31
P.O. BOX 35
JUNGINGEN,  DE D-72417
Applicant Contact PATRICIA RIESTER-FREUDENMANN
Correspondent
RUDOLF RIESTER GMBH & CO. KG
BRUCKSTRASSE 31
P.O. BOX 35
JUNGINGEN,  DE D-72417
Correspondent Contact PATRICIA RIESTER-FREUDENMANN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received09/22/2000
Decision Date 12/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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