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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 K973972
Device Name PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
Applicant
Perfect Ear
130 E. Evergreen Ave.,
Unit 108-C
Longwood,  FL  32750
Applicant Contact DON CAMPBELL
Correspondent
Perfect Ear
130 E. Evergreen Ave.,
Unit 108-C
Longwood,  FL  32750
Correspondent Contact DON CAMPBELL
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/20/1997
Decision Date 11/04/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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