Sauflon Multipurpose Solution - No Rub
FDA 510(k) K030278 · Sauflon Pharmaceuticals, Ltd.
510(k) numberK030278
Submission
- Device name
- Sauflon Multipurpose Solution - No Rub
- Applicant
- Sauflon Pharmaceuticals, Ltd.
Twickenham, Middlesex, GB - Received
- January 27, 2003
- Decision date
- July 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPN – Accessories, Soft Lens Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
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More from Alcon Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133740 | Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal…LPL · Traditional | 03/05/2014SE |
| K130342 | Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerLPL · Traditional | 08/05/2013SE |
| K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…MVN · Traditional | 07/26/2013SE |
| K130734 | Sauflon Multipurpose SolutionLPN · Traditional | 05/15/2013SE |
| K052832 | Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact LensesMVN · Traditional | 05/15/2006SE |
| K052809 | Sauflon Flat Coloured Lens CaseLRX · Traditional | 11/02/2005SE |
| K033656 | Sauflon Flat Lens Case/Sauflon 2003 Barrel Lens CaseLRX · Traditional | 02/02/2004SE |
| K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact LensLPL · Traditional | 12/26/2001SE |
| K010559 | Sauflon Multi Lens Care SystemLPN · Traditional | 12/20/2001SE |
| K011456 | Delta Plus Multiaction Solution for Rigid Gas Permeable Contact LensesMRC · Traditional | 07/17/2001SE |
Questions and answers
When was Sauflon Multipurpose Solution - No Rub cleared by the FDA?
Sauflon Multipurpose Solution - No Rub (K030278) received a 510(k) decision of Substantially Equivalent on July 30, 2003, 184 days after the submission was received.
What is the product code of K030278?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.