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FDA 510(k) Application Details - K031416
Device Classification Name
Blood Pressure Cuff
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510(K) Number
K031416
Device Name
Blood Pressure Cuff
Applicant
CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE, WA 98005 US
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Contact
LANE ABENROTH
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
05/05/2003
Decision Date
07/15/2003
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
Y
Expedited Review
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