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FDA 510(k) Application Details - K012553
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K012553
Device Name
Blood Pressure Cuff
Applicant
GLOBALSHOP, INC.
1156 EAST RIDGEWOOD AVE.
PO BOX 1211
RIDGEWOOD, NJ 07450 US
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Contact
GARY C BAUMAN
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Regulation Number
870.1120
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Classification Product Code
DXQ
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More FDA Info for this Product Code
Date Received
08/08/2001
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
Y
Expedited Review
FDA Source Information for K012553
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