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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 K896072
Device Name D.L. SCOPE OPHTHALMOSCOPE
Applicant
North American Medical Products, Inc.
6 White Fir Dr.
Loudonville,  NY  12211
Applicant Contact ARTHUR GIANAKOS
Correspondent
North American Medical Products, Inc.
6 White Fir Dr.
Loudonville,  NY  12211
Correspondent Contact ARTHUR GIANAKOS
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received10/19/1989
Decision Date 11/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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