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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 K854637
Device Name LEE ELECTRONICS PAL
Applicant
Lee Electronics
983 NW Spruce St.
Corvallis,  OR  97330
Applicant Contact PETER A LEE
Correspondent
Lee Electronics
983 NW Spruce St.
Corvallis,  OR  97330
Correspondent Contact PETER A LEE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/19/1985
Decision Date 04/29/1986
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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