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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
510(k) Number K844761
Device Name SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD
Applicant
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
2235 POLVOROSA AVE.
SUITE 200
SAN LEANDRO,  CA  94577
Applicant Contact WILLIAM T GEORGE
Correspondent
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
2235 POLVOROSA AVE.
SUITE 200
SAN LEANDRO,  CA  94577
Correspondent Contact WILLIAM T GEORGE
Regulation Number886.4750
Classification Product Code
HOY  
Date Received12/07/1984
Decision Date 12/24/1984
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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