The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for Benz-g 4x Hioxifilcon D.
Device ID | K062854 |
510k Number | K062854 |
Device Name: | BENZ-G 4X HIOXIFILCON D |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Contact | Arthur J Ward |
Correspondent | Arthur J Ward BENZ RESEARCH AND DEVELOPMENT CORP. 962 ALLEGRO LANE Apollo Beach, FL 33572 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-09-25 |
Decision Date | 2007-08-06 |
Summary: | summary |