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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 K933222
Device Name AUDIOMETER DA 323
Applicant
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Applicant Contact MICHAEL DAVIDSON
Correspondent
FUTUREMED DIV. OF FUTURE IMPEX CORP.
2076 DEER PARK AVE.
DEER PARK,  NY  11729
Correspondent Contact MICHAEL DAVIDSON
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/01/1993
Decision Date 11/01/1993
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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