FDA 510(k) Application Details - K122058

Device Classification Name Blood Pressure Cuff

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510(K) Number K122058
Device Name Blood Pressure Cuff
Applicant WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS, NY 13153-0220 US
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Contact KEVIN CROSSEN
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 07/13/2012
Decision Date 11/05/2012
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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