K915808 is an FDA 510(k) clearance for the AQUEOUS PARACENTESIS PIPET. This device is classified as a Device, Irrigation, Ocular Surgery (Class I - General Controls, product code KYG).
Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on March 19, 1992, 86 days after receiving the submission on December 24, 1991.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4360.
| 510(k) Number | K915808 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 1991 |
| Decision Date | March 19, 1992 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYG — Device, Irrigation, Ocular Surgery |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4360 |