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FDA 510(k) Application Details - K032821
Device Classification Name
Reprocessed Blood Pressure Cuff
More FDA Info for this Device
510(K) Number
K032821
Device Name
Reprocessed Blood Pressure Cuff
Applicant
HYGIA HEALTH SERVICES, INC.
434 INDUSTRIAL LN.
BIRMINGHAM, AL 35211 US
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Contact
TRACY W COMAS
Other 510(k) Applications for this Contact
Regulation Number
870.1120
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Classification Product Code
NPP
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More FDA Info for this Product Code
Date Received
09/05/2003
Decision Date
12/05/2003
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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