The following data is part of a premarket notification filed by Byron Medical with the FDA for Byron Medical Aspiration And Infiltration/irrigation Tubing.
| Device ID | K974295 |
| 510k Number | K974295 |
| Device Name: | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING |
| Classification | Accessories, Catheter |
| Applicant | BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Contact | Todd Lane |
| Correspondent | Todd Lane BYRON MEDICAL 3280 E. HEMISPHERE LOOP SUITE 100 Tucson, AZ 85706 |
| Product Code | KGZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-14 |
| Decision Date | 1998-02-10 |
| Summary: | summary |