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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 K151509
Device Name GSI TympStar Pro Middle Ear Analyzer
Applicant
Diagnostic Group, Dba Grason-Stadler
7625 Golden Triangle Dr., Suite F
Eden Prairie,  MN  55344
Applicant Contact Ron Rolfsen
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number874.1090
Classification Product Code
ETY  
Date Received06/04/2015
Decision Date 06/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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