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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 K853967
Device Name HI-TECH LAB MODEL CONCHA ALL IN EAR
Applicant
Hi-Tech Laboratories, Inc.
P.O. Box 1330
1008 A St.
Blue Springs,  MO  64015
Applicant Contact HOWARD E SANDER
Correspondent
Hi-Tech Laboratories, Inc.
P.O. Box 1330
1008 A St.
Blue Springs,  MO  64015
Correspondent Contact HOWARD E SANDER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/26/1985
Decision Date 12/27/1985
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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