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FDA 510(k) Application Details - K033579
Device Classification Name
Clip, Implantable, Reprocessed
More FDA Info for this Device
510(K) Number
K033579
Device Name
Clip, Implantable, Reprocessed
Applicant
CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE, WA 98005 US
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Contact
MIKE KOVACS
Other 510(k) Applications for this Contact
Regulation Number
878.4300
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Classification Product Code
NMJ
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More FDA Info for this Product Code
Date Received
11/13/2003
Decision Date
07/11/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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