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FDA 510(k) Application Details - K033591
Device Classification Name
Trocar, Sinus
More FDA Info for this Device
510(K) Number
K033591
Device Name
Trocar, Sinus
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
874.4420
More FDA Info for this Regulation Number
Classification Product Code
KBG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/13/2003
Decision Date
06/03/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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