The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Swabbable Cap, Model 60205.
| Device ID | K070163 |
| 510k Number | K070163 |
| Device Name: | SWABBABLE CAP, MODEL 60205 |
| Classification | Administration Set Docking Station |
| Applicant | BAXA CORP. 14445 GRASSLANDS DR. Englewood, CO 80112 -7062 |
| Contact | Kimberly Zizik |
| Correspondent | Kimberly Zizik BAXA CORP. 14445 GRASSLANDS DR. Englewood, CO 80112 -7062 |
| Product Code | ODI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-17 |
| Decision Date | 2007-08-03 |
| Summary: | summary |