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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 K903066
Device Name AMPLAID 770 ADMITTANCE METER
Applicant
AMPLUS CORP.
65 BRISTLECONE WAY
BOULDER,  CO  80304
Applicant Contact GIAN MAZZONI
Correspondent
AMPLUS CORP.
65 BRISTLECONE WAY
BOULDER,  CO  80304
Correspondent Contact GIAN MAZZONI
Regulation Number874.1090
Classification Product Code
ETY  
Date Received07/12/1990
Decision Date 10/24/1990
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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