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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reader, Bar, Ophthalmic
510(k) Number K781459
Device Name MONOJECT SCALE MAGNIFIER
Applicant
SHERWOOD MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SHERWOOD MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.5800
Classification Product Code
HJY  
Date Received08/23/1978
Decision Date 10/24/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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