The following data is part of a premarket notification filed by Gelflex Laboratories with the FDA for Gelflex Delta 55 (methafilcon A) Hydrophilic Contact Lens.
| Device ID | K962710 |
| 510k Number | K962710 |
| Device Name: | GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | GELFLEX LABORATORIES 3 HUTTON ST., OSBORNE PARK Perth, Western, Wa, AU 6017 |
| Contact | Peter G Bryant |
| Correspondent | Peter G Bryant GELFLEX LABORATORIES 3 HUTTON ST., OSBORNE PARK Perth, Western, Wa, AU 6017 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-10 |
| Decision Date | 1996-09-05 |