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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 K970324
Device Name GSI SA60 DPOAE SYSTEM
Applicant
Grason-Stadler, Inc.
1 Westchester Dr.
Milford,  NH  03055
Applicant Contact NORMAN L SCHULTZ
Correspondent
Grason-Stadler, Inc.
1 Westchester Dr.
Milford,  NH  03055
Correspondent Contact NORMAN L SCHULTZ
Regulation Number874.3310
Classification Product Code
ETW  
Date Received01/27/1997
Decision Date 06/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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