The following data is part of a premarket notification filed by Sauflon Pharmaceuticals, Ltd. with the FDA for Sauflon New Day (methafilcon A) Soft (hydrophilic) Daily Disposable Contact Lenses.
| Device ID | K052832 |
| 510k Number | K052832 |
| Device Name: | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES |
| Classification | Lens, Contact, (disposable) |
| Applicant | SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. Twickenham, Middlesex, GB Tw1-3lp |
| Contact | Tanya Fair |
| Correspondent | Tanya Fair SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. Twickenham, Middlesex, GB Tw1-3lp |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-06 |
| Decision Date | 2006-05-15 |
| Summary: | summary |