The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Suction/irrigation Y Tubing Set W/trumpet Valves.
| Device ID | K930512 |
| 510k Number | K930512 |
| Device Name: | SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES |
| Classification | Tubing, Noninvasive |
| 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 | GAZ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-01 |
| Decision Date | 1993-07-23 |