The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Rapid-fill Tubeset, Model 90005.
| Device ID | K022523 |
| 510k Number | K022523 |
| Device Name: | RAPID-FILL TUBESET, MODEL 90005 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood, CO 80112 -3903 |
| Contact | Karl Steinbeck |
| Correspondent | Karl Steinbeck BAXA CORP. 13760 EAST ARAPAHOE RD. Englewood, CO 80112 -3903 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-30 |
| Decision Date | 2002-08-12 |
| Summary: | summary |