Submission Details
| 510(k) Number | K980147 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 15, 1998 |
| Decision Date | April 13, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
K980147 is an FDA 510(k) clearance for the YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Automatic Liquid Packaging, Inc. (Chicago, US). The FDA issued a Cleared decision on April 13, 1998, 88 days after receiving the submission on January 15, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K980147 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 15, 1998 |
| Decision Date | April 13, 1998 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |