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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 K930858
Device Name MODISSA 90 S.R.L. SUNGLASSES
Applicant
Modissa 90 Srl
124, Strada Statale Cisa 62
Porto Mantovano, Mn,  IT 46047
Applicant Contact ANGELO ORSINI
Correspondent
Modissa 90 Srl
124, Strada Statale Cisa 62
Porto Mantovano, Mn,  IT 46047
Correspondent Contact ANGELO ORSINI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/18/1993
Decision Date 10/20/1993
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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