The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for Benz Methafilcon A Optical Blank, Benz Methafilcon A Spherical And Toric Soft (hydrophilic) Contact Lenses For Daily Wer.
Device ID | K980418 |
510k Number | K980418 |
Device Name: | BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. 1070 THORNWOOD LN. Dacula, GA 30019 |
Contact | Michael A Clark |
Correspondent | Michael A Clark BENZ RESEARCH AND DEVELOPMENT CORP. 1070 THORNWOOD LN. Dacula, GA 30019 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-03 |
Decision Date | 1998-02-27 |
Summary: | summary |