The following data is part of a premarket notification filed by Nike, Inc. with the FDA for Magneto Eyewear.
Device ID | K962169 |
510k Number | K962169 |
Device Name: | MAGNETO EYEWEAR |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | NIKE, INC. ONE BOWERMAN DR. Beaverton, OR 97005 -6453 |
Contact | Andrew P Mooney |
Correspondent | Andrew P Mooney NIKE, INC. ONE BOWERMAN DR. Beaverton, OR 97005 -6453 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-05 |
Decision Date | 1996-06-24 |