The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for Benz G-5x (hioxifilcon A) Soft Daily Wear Contact Lens.
Device ID | K983773 |
510k Number | K983773 |
Device Name: | BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 623 GLACIER DR. Grand Junction, CO 81503 |
Contact | Martin Dalsing |
Correspondent | Martin Dalsing BENZ RESEARCH AND DEVELOPMENT CORP. 623 GLACIER DR. Grand Junction, CO 81503 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-26 |
Decision Date | 1998-12-22 |