The following data is part of a premarket notification filed by Nike, Inc. with the FDA for Nike V8 And Nike V12.
Device ID | K962412 |
510k Number | K962412 |
Device Name: | NIKE V8 AND NIKE V12 |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | NIKE, INC. 10001 G STREET, N.W. SUITE 500W Washington, DC 20001 |
Contact | John B Dubeck |
Correspondent | John B Dubeck NIKE, INC. 10001 G STREET, N.W. SUITE 500W Washington, DC 20001 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-21 |
Decision Date | 1996-07-03 |