The following data is part of a premarket notification filed by Controlled Flow Ltd. with the FDA for Sta-set I.v. Flow Regulator.
| Device ID | K880006 |
| 510k Number | K880006 |
| Device Name: | STA-SET I.V. FLOW REGULATOR |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | CONTROLLED FLOW LTD. 12705 SOUTH KIRKWOOD 220 Stafford, TX 77477 |
| Contact | Matthew O'boyle |
| Correspondent | Matthew O'boyle CONTROLLED FLOW LTD. 12705 SOUTH KIRKWOOD 220 Stafford, TX 77477 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-04 |
| Decision Date | 1988-03-24 |