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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 K852052
Device Name HEARING AID(ALL IN THE EAR(ALL IN THE CANAL
Applicant
Penn-Tech Laboratories
153 W. Fourth St. 4th.Flr
Williamsport,  PA  17701
Applicant Contact WILLIAM G HITCHENS
Correspondent
Penn-Tech Laboratories
153 W. Fourth St. 4th.Flr
Williamsport,  PA  17701
Correspondent Contact WILLIAM G HITCHENS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received05/09/1985
Decision Date 08/16/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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