FDA 510(k) Application Details - K012455

Device Classification Name Blood Pressure Cuff

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510(K) Number K012455
Device Name Blood Pressure Cuff
Applicant WELCH ALLYN, INC.
95 OLD SHOALS RD.
ARDEN, NC 28704 US
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Contact DAVID A YOUNG
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 08/01/2001
Decision Date 08/17/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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