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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 K003376
Device Name WELCH ALLYN 11800 OPTHALMOSCOPE
Applicant
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Applicant Contact COLIN WOLFF
Correspondent
WELCH ALLYN, INC.
4341 STATE ST. RD.
P.O. BOX 220
SKANEATELES FALLS,  NY  13153 -0220
Correspondent Contact COLIN WOLFF
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
HLJ  
Date Received10/30/2000
Decision Date 01/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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