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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 K862661
Device Name D.L. SCOPE(R) OTOSCOPE
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 Number874.4770
Classification Product Code
ERA  
Date Received07/14/1986
Decision Date 08/08/1986
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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