Submission Details
| 510(k) Number | K941883 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 1994 |
| Decision Date | October 28, 1994 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
CONTACT LENS
Oct 1994
Decision
193d
Days
Class 2
Risk
About This 510(k) Submission
K941883 is an FDA 510(k) clearance for the CONTACT LENS, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Airperm, Inc. (Sherman Oaks, US). The FDA issued a Cleared decision on October 28, 1994, 193 days after receiving the submission on April 18, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.
Device Classification
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5916 |
Manufacturer
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