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510(k) Premarket Notification

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Device Classification Name sunglasses (non-prescription including photosensitive)
510(k) NumberK953002
Device NameMETAL FRAM WITH POLYCARBONATE LENS
Applicant
NAKANISHI OPTICAL PRODUCTS CORP.
no. 1 osaka ekimae bldg., 3-1-
1000, umed
1-chome, kita-ku,, 
Contactosamu inoue
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/28/1995
Decision Date 07/12/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Statement/Summary/Purged Status Statement only
Type Traditional
Reviewed by Third Party No
Expedited Review
 
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