Submission Details
| 510(k) Number | K052832 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 06, 2005 |
| Decision Date | May 15, 2006 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
May 2006
Decision
221d
Days
Class 2
Risk
About This 510(k) Submission
K052832 is an FDA 510(k) clearance for the SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES, a Lens, Contact, (disposable) (Class II — Special Controls, product code MVN), submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on May 15, 2006, 221 days after receiving the submission on October 6, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.
Device Classification
| Product Code | MVN — Lens, Contact, (disposable) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5925 |
Manufacturer
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