Submission Details
| 510(k) Number | K033608 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2003 |
| Decision Date | February 02, 2004 |
| Days to Decision | 77 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Special
AQUIFY MULTI-PURPOSE SOLUTION
Feb 2004
Decision
77d
Days
Class 2
Risk
About This 510(k) Submission
K033608 is an FDA 510(k) clearance for the AQUIFY MULTI-PURPOSE SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on February 2, 2004, 77 days after receiving the submission on November 17, 2003. 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
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