The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Bifurcated Suction/irrigat Tubing Set W/push Butto.
| Device ID | K926477 |
| 510k Number | K926477 |
| Device Name: | BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO |
| Classification | Catheter, Peritoneal |
| Applicant | CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246 |
| Contact | Tim Reis |
| Correspondent | Tim Reis CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246 |
| Product Code | GBW |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-29 |
| Decision Date | 1993-11-12 |