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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 K880059
Device Name AMPLAID 309 CLINICAL AUDIOMETER
Applicant
Amplus Corp.
65 Bristlecone Way
Boulder,  CO  80304
Applicant Contact MARGARET MIZZONI
Correspondent
Amplus Corp.
65 Bristlecone Way
Boulder,  CO  80304
Correspondent Contact MARGARET MIZZONI
Regulation Number874.1050
Classification Product Code
EWO  
Date Received01/07/1988
Decision Date 02/23/1988
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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