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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 K770768
Device Name OPHTHALMOSCOPE, MODEL #11100
Applicant
WELCH ALLYN, INC.
Skaneateles Falls
Skaneateles,  NY  13153
Applicant Contact Richard W. Newman
Correspondent
WELCH ALLYN, INC.
Skaneateles Falls
Skaneateles,  NY  13153
Correspondent Contact Richard W. Newman
Regulation Number886.1570
Classification Product Code
HLI  
Date Received04/28/1977
Decision Date 05/06/1977
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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