The following data is part of a premarket notification filed by Cardiomed Supplies, Inc. with the FDA for Phlebotomy Bag With Valve & 17g X 1, Model Cm-ph17x1b, Cm-ph17x1c.
| Device ID | K080174 |
| 510k Number | K080174 |
| Device Name: | PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CARDIOMED SUPPLIES, INC. 199 ST. DAVID STREET Lindsay-ontario, CA K9v 5k7 |
| Contact | Christian G Dube |
| Correspondent | Christian G Dube CARDIOMED SUPPLIES, INC. 199 ST. DAVID STREET Lindsay-ontario, CA K9v 5k7 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-24 |
| Decision Date | 2008-04-23 |