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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Otoscope
510(k) Number K944897
Device Name HOME CARE EAR EXAMINATIO KIT
Applicant
Home Care Instruments, Inc.
5251 Duke St.
Alexandria,  VA  22304
Applicant Contact JOSEPH MILLER
Correspondent
Home Care Instruments, Inc.
5251 Duke St.
Alexandria,  VA  22304
Correspondent Contact JOSEPH MILLER
Regulation Number874.4770
Classification Product Code
ERA  
Date Received10/04/1994
Decision Date 11/08/1994
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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