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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 K821765
Device Name PHOTOTHERAPY EYE PROTECTION FOR INFANTS
Applicant
RUSSELL TERRY CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RUSSELL TERRY CO.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number886.4750
Classification Product Code
HOY  
Date Received06/14/1982
Decision Date 08/16/1982
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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