The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Sureconnect Closed Drug Reconstitution And Transfer System.
| Device ID | K090917 |
| 510k Number | K090917 |
| Device Name: | SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | BAXA CORP. 14445 GRASSLANDS DR. Englewood, CO 80112 -7062 |
| Contact | Jim Morgan |
| Correspondent | Jim Morgan BAXA CORP. 14445 GRASSLANDS DR. Englewood, CO 80112 -7062 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2010-02-19 |