The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Baxa Pca Infusor.
| Device ID | K910257 |
| 510k Number | K910257 |
| Device Name: | BAXA PCA INFUSOR |
| Classification | Pump, Infusion, Pca |
| Applicant | BAXA CORP., SUB. OF COOK GROUP, INC. 13760 E. ARAPAHOE RD. Englewood, CO 80112 |
| Contact | Mary Steggall |
| Correspondent | Mary Steggall BAXA CORP., SUB. OF COOK GROUP, INC. 13760 E. ARAPAHOE RD. Englewood, CO 80112 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-11-07 |