The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Vented I.v. Transfer Needle.
| Device ID | K832332 |
| 510k Number | K832332 |
| Device Name: | VENTED I.V. TRANSFER NEEDLE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXA CORP., SUB. OF COOK GROUP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-09-12 |