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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 K920911
Device Name QCC CUSTOM CANAL AND QE1 ALL ITE
Applicant
Qualitech Electronics, Inc.
14453 S. Dixie Hwy.
Miami,  FL  33176
Applicant Contact MR.CARLOS E BENDANA
Correspondent
Qualitech Electronics, Inc.
14453 S. Dixie Hwy.
Miami,  FL  33176
Correspondent Contact MR.CARLOS E BENDANA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/27/1992
Decision Date 04/27/1992
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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