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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 K960410
Device Name PERFECT EAR PE/PE-AGC/PE-B/PE-PWR
Applicant
Perfect Ear
P.O. Box 958405
Lake Mary,  FL  32795
Applicant Contact DONALD E K CAMPBELL
Correspondent
Perfect Ear
P.O. Box 958405
Lake Mary,  FL  32795
Correspondent Contact DONALD E K CAMPBELL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/29/1996
Decision Date 04/04/1996
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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