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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K934658
Device Name GSI 60 DPOAE SYSTEM
Applicant
Lucas Grason-Stadler, Inc.
1 Westchester Dr.
Milford,  NH  03055
Applicant Contact JANICE E PAINTER
Correspondent
Lucas Grason-Stadler, Inc.
1 Westchester Dr.
Milford,  NH  03055
Correspondent Contact JANICE E PAINTER
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/28/1993
Decision Date 02/01/1994
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
Predetermined Change
Control Plan Authorized		 No
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