Submission Details
| 510(k) Number | K130734 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 18, 2013 |
| Decision Date | May 15, 2013 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
SAUFLON MULTIPURPOSE SOLUTION
May 2013
Decision
58d
Days
Class 2
Risk
About This 510(k) Submission
K130734 is an FDA 510(k) clearance for the SAUFLON MULTIPURPOSE SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on May 15, 2013, 58 days after receiving the submission on March 18, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
Sauflon Pharmaceuticals, Ltd.
Twickenham, Middlesex · GB
CHRISTOPHER SMEJKAL
12 submissions
12 cleared
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