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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 K823588
Device Name PERSONAL ROMEAR
Applicant
ROMEAR MFG., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ROMEAR MFG., INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/06/1982
Decision Date 04/27/1983
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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