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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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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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