Submission Details
| 510(k) Number | K052809 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 04, 2005 |
| Decision Date | November 02, 2005 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
SAUFLON FLAT COLOURED LENS CASE
Nov 2005
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K052809 is an FDA 510(k) clearance for the SAUFLON FLAT COLOURED LENS CASE, a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on November 2, 2005, 29 days after receiving the submission on October 4, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LRX — Case, Contact Lens |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
Sauflon Pharmaceuticals, Ltd.
Twickenham, Middlesex · GB
AZITTA JADALIZADEH
12 submissions
12 cleared
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