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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectacle, Magnifying
510(k) Number K842835
Device Name BRILLETTE MODEL
Applicant
Cillus Company, Inc.
36 Pacheco Creek Dr.
Novato,  CA  94947
Applicant Contact JORGEN L KREJSBOL
Correspondent
Cillus Company, Inc.
36 Pacheco Creek Dr.
Novato,  CA  94947
Correspondent Contact JORGEN L KREJSBOL
Regulation Number886.5840
Classification Product Code
HOI  
Date Received07/20/1984
Decision Date 11/21/1984
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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