The following data is part of a premarket notification filed by Infucare Products, Inc. with the FDA for Infucare Syringe Pump Tubing Set.
| Device ID | K914034 |
| 510k Number | K914034 |
| Device Name: | INFUCARE SYRINGE PUMP TUBING SET |
| Classification | Pump, Infusion |
| Applicant | INFUCARE PRODUCTS, INC. 917 KLOSTERMAN RD.E Tarpon Springs, FL 34689 |
| Contact | Don Ryan |
| Correspondent | Don Ryan INFUCARE PRODUCTS, INC. 917 KLOSTERMAN RD.E Tarpon Springs, FL 34689 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-10 |
| Decision Date | 1991-10-30 |