K923972 is an FDA 510(k) clearance for the OPHTHALMIC FLUID DISTRIBUTION SETS. This device is classified as a Tubing, Fluid Delivery (Class II - Special Controls, product code FPK).
Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on November 4, 1992, 89 days after receiving the submission on August 7, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K923972 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1992 |
| Decision Date | November 04, 1992 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPK — Tubing, Fluid Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |