FDA 510(k) Application Details - K972378

Device Classification Name Blood Pressure Cuff

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510(K) Number K972378
Device Name Blood Pressure Cuff
Applicant RUDOLF RIESTER GMBH & CO. KG
BRUCKSTRASSE 31
P.O. BOX 35
JUNGINGEN D-72417 DE
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Contact PATRICIA RIESTER FREUDENMANN
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 06/26/1997
Decision Date 09/24/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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