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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K871652
Device Name NEUROCOM PRESSURE TEST SYSTEM
Applicant
Neurocom International, Inc.
9570 SE Lawnfield Rd.
Clackamas,  OR  97015
Applicant Contact JACK KELLY
Correspondent
Neurocom International, Inc.
9570 SE Lawnfield Rd.
Clackamas,  OR  97015
Correspondent Contact JACK KELLY
Regulation Number874.1090
Classification Product Code
ETY  
Date Received04/28/1987
Decision Date 07/16/1987
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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