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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 K945922
Device Name NON-PRESCRIPTION SUNGLASSES
Applicant
Csi Industries, Inc.
450 Winks Ln.
Bensalem,  PA  19020
Applicant Contact KATHLEEN LIEBERMAN
Correspondent
Csi Industries, Inc.
450 Winks Ln.
Bensalem,  PA  19020
Correspondent Contact KATHLEEN LIEBERMAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/05/1994
Decision Date 03/03/1995
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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