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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 K832361
Device Name CONCEPT T-TUBE
Applicant
Concept, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Concept, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.3880
Classification Product Code
ETD  
Date Received07/18/1983
Decision Date 10/14/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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