K934204 is an FDA 510(k) clearance for the INTERTIP INFUSION SET. This device is classified as a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II - Special Controls, product code HQE).
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on February 7, 1994, 161 days after receiving the submission on August 30, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4150.
| 510(k) Number | K934204 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 1993 |
| Decision Date | February 07, 1994 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQE - Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4150 |