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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 K900942
Device Name OCULAR OCCLUDER
Applicant
Microdynamics
9037 Arrow Rte.
Suite 100
Rancho Cucamonga,  CA  91730
Applicant Contact RICHARD ROTHERMUND
Correspondent
Microdynamics
9037 Arrow Rte.
Suite 100
Rancho Cucamonga,  CA  91730
Correspondent Contact RICHARD ROTHERMUND
Regulation Number886.4750
Classification Product Code
HOY  
Date Received02/28/1990
Decision Date 05/25/1990
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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