The following data is part of a premarket notification filed by Bionomy, Inc. with the FDA for Bionomy's Multi-lumen Central Venous Catheter-set.
| Device ID | K851101 |
| 510k Number | K851101 |
| Device Name: | BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SET |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | BIONOMY, INC. P.O. BOX 270882 Tampa, FL 33688 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul BIONOMY, INC. P.O. BOX 270882 Tampa, FL 33688 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-19 |
| Decision Date | 1985-04-12 |