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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K141638
Device Name PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
Applicant
Propper Manufacturing Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Applicant Contact ANDREW SHARAVARA
Correspondent
Propper Manufacturing Co., Inc.
36-04 Skillman Ave.
Long Island,  NY  11101
Correspondent Contact ANDREW SHARAVARA
Regulation Number886.1570
Classification Product Code
HLI  
Date Received06/19/2014
Decision Date 09/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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