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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K950963
Device Name AUDIOTECH MODEL SPI
Applicant
MUSKOGEE REGIONAL HEARING AID LAB
2019 WEST BROADWAY
MUSKOGEE,  OK  74401
Applicant Contact DON LANGSTON
Correspondent
MUSKOGEE REGIONAL HEARING AID LAB
2019 WEST BROADWAY
MUSKOGEE,  OK  74401
Correspondent Contact DON LANGSTON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/02/1995
Decision Date 05/25/1995
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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