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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 K960953
Device Name SUNGLASSES
Applicant
Galilee Optics
11611 Old Georgetown Rd.
Rockville,  MD  20852
Applicant Contact MARC H AST
Correspondent
Galilee Optics
11611 Old Georgetown Rd.
Rockville,  MD  20852
Correspondent Contact MARC H AST
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/11/1996
Decision Date 05/31/1996
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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