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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 K961945
Device Name TYMPANOSTOMY VENTILATION TUBE
Applicant
Advanced Microbotics Corp.
2611 SW 3rd. Ave., Suite 200
Portland,  OR  97201
Applicant Contact ANTHONY W HUMPAGE
Correspondent
Advanced Microbotics Corp.
2611 SW 3rd. Ave., Suite 200
Portland,  OR  97201
Correspondent Contact ANTHONY W HUMPAGE
Regulation Number874.3880
Classification Product Code
ETD  
Date Received05/20/1996
Decision Date 06/11/1996
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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