NIKE V8 AND NIKE V12

Sunglasses (non-prescription Including Photosensitive)

NIKE, INC.

The following data is part of a premarket notification filed by Nike, Inc. with the FDA for Nike V8 And Nike V12.

Pre-market Notification Details

Device IDK962412
510k NumberK962412
Device Name:NIKE V8 AND NIKE V12
ClassificationSunglasses (non-prescription Including Photosensitive)
Applicant NIKE, INC. 10001 G STREET, N.W. SUITE 500W Washington,  DC  20001
ContactJohn B Dubeck
CorrespondentJohn B Dubeck
NIKE, INC. 10001 G STREET, N.W. SUITE 500W Washington,  DC  20001
Product CodeHQY  
CFR Regulation Number886.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-21
Decision Date1996-07-03

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