The following data is part of a premarket notification filed by Million Hu Corp. with the FDA for Running Sunglasses.
Device ID | K945808 |
510k Number | K945808 |
Device Name: | RUNNING SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | MILLION HU CORP. P.O. BOX 112-189 Taipei, TW R.o.c. |
Contact | Million Hu |
Correspondent | Million Hu MILLION HU CORP. P.O. BOX 112-189 Taipei, TW R.o.c. |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-28 |
Decision Date | 1995-04-10 |