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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Hearing Aid / Earphone And Analysis Systems
510(k) Number K943460
Device Name PORTAREM 2000
Applicant
STARKEY LABORATORIES, INC.
6600 & 6700 WASHINGTON AVE SO
EDEN PRAIRIE,  MN  55344
Applicant Contact RICK STROMBERG
Correspondent
STARKEY LABORATORIES, INC.
6600 & 6700 WASHINGTON AVE SO
EDEN PRAIRIE,  MN  55344
Correspondent Contact RICK STROMBERG
Regulation Number874.3310
Classification Product Code
ETW  
Subsequent Product Code
EWO  
Date Received07/18/1994
Decision Date 10/21/1994
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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