Submission Details
| 510(k) Number | K974624 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 11, 1997 |
| Decision Date | March 04, 1998 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
Mar 1998
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K974624 is an FDA 510(k) clearance for the ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on March 4, 1998, 83 days after receiving the submission on December 11, 1997. 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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