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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 K921257
Device Name EURION LOTOS P HEARING AID
Applicant
Manro Corp.
2949 Dawes, SE
Grand Rapids,  MI  49508
Applicant Contact ROBERT A CUNNINGHAM
Correspondent
Manro Corp.
2949 Dawes, SE
Grand Rapids,  MI  49508
Correspondent Contact ROBERT A CUNNINGHAM
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/16/1992
Decision Date 05/15/1992
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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