The following data is part of a premarket notification filed by Benz Research And Development Corp. with the FDA for Extreme H20 (hioxifilicon A) Soft Contact Lens.
| Device ID | K992692 |
| 510k Number | K992692 |
| Device Name: | EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BENZ RESEARCH AND DEVELOPMENT CORP. P.O. BOX 1839 Sarasota, FL 34230 -1839 |
| Contact | Jose A Ors |
| Correspondent | Jose A Ors BENZ RESEARCH AND DEVELOPMENT CORP. P.O. BOX 1839 Sarasota, FL 34230 -1839 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-11 |
| Decision Date | 1999-10-18 |
| Summary: | summary |