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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 K880286
Device Name OMNI ITC TYPE HEARING AID MODEL U-IMPULSE SP
Applicant
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact ROBERT F GAMES
Correspondent
Richards Medical Co., Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact ROBERT F GAMES
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/25/1988
Decision Date 02/23/1988
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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