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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name trocar, sinus
510(k) Number K033591
Device Name REPROCESSED TROCARS
Applicant
CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE,  WA  98005
Applicant Contact MIKE KOVACS
Correspondent
CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE,  WA  98005
Correspondent Contact MIKE KOVACS
Regulation Number874.4420
Classification Product Code
KBG  
Date Received11/13/2003
Decision Date 06/03/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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