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FDA 510(k) Application Details - K954282
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.1120
More FDA Info for this Regulation Number
Classification Product Code
DXQ
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More FDA Info for this Product Code
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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