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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, battery-powered
510(k) Number K843897
Device Name POCKET OPHTHALMOSCOPE GH
Applicant
DESIGN MED. CORP.
P.O. BOX 782
LAKE FOREST,  IL  60045
Applicant Contact CONRAD M SWARTZ
Correspondent
DESIGN MED. CORP.
P.O. BOX 782
LAKE FOREST,  IL  60045
Correspondent Contact CONRAD M SWARTZ
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received10/03/1984
Decision Date 11/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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