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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 K893528
Device Name OTICON I22P CUSTOM FULL CONCHA (ITE) HRNG AID
Applicant
Oticon Corp.
29 Schoolhouse Rd.
P.O. Box 6724
Somerset,  NJ  08873
Applicant Contact ROBERT MARTIN
Correspondent
Oticon Corp.
29 Schoolhouse Rd.
P.O. Box 6724
Somerset,  NJ  08873
Correspondent Contact ROBERT MARTIN
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/08/1989
Decision Date 08/15/1989
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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