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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 K780241
Device Name COMPRESSION MULTISONIC
Applicant
Qualitone
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Qualitone
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/13/1978
Decision Date 02/17/1978
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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