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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 K921685
Device Name SOLAZ
Applicant
Solarchromic, Inc.
2103 Essex Ln.
Colorado Springs,  CO  80909
Applicant Contact GARY E MUELLER
Correspondent
Solarchromic, Inc.
2103 Essex Ln.
Colorado Springs,  CO  80909
Correspondent Contact GARY E MUELLER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/07/1992
Decision Date 09/02/1992
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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