The following data is part of a premarket notification filed by Visco Vision Inc. with the FDA for Visco Soft Contact Lens.
Device ID | K141348 |
510k Number | K141348 |
Device Name: | VISCO SOFT CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | VISCO VISION INC. 6F NO 39, LN 224, JIXIAN RD New Taipei, Luzhou Dist, TW 247 |
Contact | Jennifer Ting |
Correspondent | Jennifer Ting VISCO VISION INC. 6F NO 39, LN 224, JIXIAN RD New Taipei, Luzhou Dist, TW 247 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-22 |
Decision Date | 2015-06-22 |
Summary: | summary |