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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 K833246
Device Name TYMPANOSTOMY TUBES-VARIOUS
Applicant
Abco Dealers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Abco Dealers, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.3880
Classification Product Code
ETD  
Date Received09/08/1983
Decision Date 01/04/1985
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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