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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name microdebrider, ent, high speed, single use, reprocessed
510(k) Number K142022
Device Name MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES
Applicant
MEDLINE RENEWAL
2747 SW 6th St
REDMOND,  OR  97756
Applicant Contact RICHARD D WYNKOOP
Correspondent
MEDLINE RENEWAL
2747 SW 6th St
REDMOND,  OR  97756
Correspondent Contact RICHARD D WYNKOOP
Regulation Number874.4140
Classification Product Code
NLY  
Date Received07/25/2014
Decision Date 12/19/2014
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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