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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tympanostomy
510(k) Number K971454
Device Name TYMPANOSTOMY VENTILATION TUBE
Applicant
IKONOS CORP.
320 S.W. 6TH. AVE., 2ND. FL.
PORTLAND,  OR  97204
Applicant Contact ROBERT E ELLIS
Correspondent
IKONOS CORP.
320 S.W. 6TH. AVE., 2ND. FL.
PORTLAND,  OR  97204
Correspondent Contact ROBERT E ELLIS
Regulation Number874.3880
Classification Product Code
ETD  
Date Received04/21/1997
Decision Date 05/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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