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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 K820833
Device Name AUDICRAFT VIP HEARING AID
Applicant
Audina Hearing Instrument
150 E Wildmere St.
P.O. Box 877
Casselberry,  FL  32750
Applicant Contact FRANK ROBILOTTA
Correspondent
Audina Hearing Instrument
150 E Wildmere St.
P.O. Box 877
Casselberry,  FL  32750
Correspondent Contact FRANK ROBILOTTA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/26/1982
Decision Date 04/09/1982
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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