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FDA 510(k) Application Details - K092604
Device Classification Name
Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K092604
Device Name
Blood Pressure Cuff
Applicant
TRIMLINE MEDICAL PRODUCTS CORP.
34 COLUMBIA AVE.
BRANCHBURG, NJ 08876 US
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Contact
NANCY SKOCYPEC
Other 510(k) Applications for this Contact
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
08/25/2009
Decision Date
10/21/2009
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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