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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 K972850
Device Name SUNGLASSES
Applicant
Indoptica, S.A.
1275 Beechnut Pl., Suite A
Pomona,  CA  91766
Applicant Contact JOHN R HONEY
Correspondent
Indoptica, S.A.
1275 Beechnut Pl., Suite A
Pomona,  CA  91766
Correspondent Contact JOHN R HONEY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/01/1997
Decision Date 09/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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