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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gauge, lens, ophthalmic
510(k) Number K801466
Device Name LEIGH MEASURING SCALE #7725
Applicant
EDWARD WECK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EDWARD WECK, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1420
Classification Product Code
HLN  
Date Received06/24/1980
Decision Date 07/28/1980
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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