The following data is part of a premarket notification filed by Vassen Co., Ltd. with the FDA for Vassen Color.
Device ID | K141699 |
510k Number | K141699 |
Device Name: | VASSEN COLOR |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | VASSEN CO., LTD. 474 NE 61ST PL. Hillsboro, OR 97124 |
Contact | Bret Andre |
Correspondent | Bret Andre VASSEN CO., LTD. 474 NE 61ST PL. Hillsboro, OR 97124 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-24 |
Decision Date | 2014-10-07 |
Summary: | summary |