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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 K895364
Device Name LID LOC
Applicant
SPECTRUM CO.
60916 TERMINAL ANNEX
LOS ANGELES,  CA  90060
Applicant Contact AMY PICKEREL
Correspondent
SPECTRUM CO.
60916 TERMINAL ANNEX
LOS ANGELES,  CA  90060
Correspondent Contact AMY PICKEREL
Regulation Number886.4750
Classification Product Code
HOY  
Date Received08/28/1989
Decision Date 10/31/1989
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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