FDA 510(k) Application Details - K974080

Device Classification Name Blood Pressure Cuff

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510(K) Number K974080
Device Name Blood Pressure Cuff
Applicant JOHNSON & JOHNSON MEDICAL, INC.
4110 GEORGE RD.
TAMPA, FL 33634 US
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Contact DARLENE T KORAB
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 10/29/1997
Decision Date 05/18/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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