The following data is part of a premarket notification filed by Valumed with the FDA for Steri-spouts; Bag-spout, Vial-spout, Transfer Mixer; Rapidflow, Vialflow, Transflow.
| Device ID | K023539 |
| 510k Number | K023539 |
| Device Name: | STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | VALUMED 1439 LIVE OAK ST. SUITE A Niceville, FL 32578 |
| Contact | Thomas E Cottone |
| Correspondent | Thomas E Cottone VALUMED 1439 LIVE OAK ST. SUITE A Niceville, FL 32578 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-22 |
| Decision Date | 2002-12-17 |
| Summary: | summary |