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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 K863474
Device Name KASEY EYE SHIELD
Applicant
Kasey Enterprises, Inc.
254 Cadwalader Ave.
Elkins Park,  PA  19117
Applicant Contact CURTIS D WINTERS
Correspondent
Kasey Enterprises, Inc.
254 Cadwalader Ave.
Elkins Park,  PA  19117
Correspondent Contact CURTIS D WINTERS
Regulation Number886.4750
Classification Product Code
HOY  
Date Received09/09/1986
Decision Date 09/24/1986
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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