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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K900382
Device Name BLUBLOCKER SUNGLASSES
Applicant
Blublocker Corp.
3100 Dundee Rd. Suite 802
Northbrook,  IL  60062
Applicant Contact JOSEPH SUGARMAN
Correspondent
Blublocker Corp.
3100 Dundee Rd. Suite 802
Northbrook,  IL  60062
Correspondent Contact JOSEPH SUGARMAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received01/25/1990
Decision Date 02/13/1990
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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