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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, spectacle, non-custom (prescription)
510(k) Number K781927
Device Name HUMAN II LENS
Applicant
SPECTRA-SHIELD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SPECTRA-SHIELD, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.5844
Classification Product Code
HQG  
Date Received11/16/1978
Decision Date 12/20/1978
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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