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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spectacle, operating (loupe), ophthalmic
510(k) Number K810817
Device Name EXETER OPERATING LOUPE
Applicant
EXETER INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
EXETER INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.4770
Classification Product Code
HOH  
Date Received03/24/1981
Decision Date 04/23/1981
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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