The following data is part of a premarket notification filed by Baxa Corp. with the FDA for Repeater Pump Ii Tube Sets.
| Device ID | K062909 |
| 510k Number | K062909 |
| Device Name: | REPEATER PUMP II TUBE SETS |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-27 |
| Decision Date | 2007-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412476693 | K062909 | 000 |
| 50085412476686 | K062909 | 000 |