FDA 510(k) Application Details - K954282

Device Classification Name Blood Pressure Cuff

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510(K) Number K954282
Device Name Blood Pressure Cuff
Applicant STATCORP, INC.
1200 COLUMBIA AVE.
P.O. BOX 1225
FRANKLIN, TN 37065 US
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Contact JAMES M SHEPHERD
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Regulation Number 870.1120

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Classification Product Code DXQ
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Date Received 09/13/1995
Decision Date 02/06/1996
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

FDA Source Information for K954282


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