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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 K832362
Device Name DONALDSON-TYPE VENT TUBE
Applicant
CONCEPT, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CONCEPT, INC.
4221 Richmond Rd., N.W.
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
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