The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Baxa Exacta-med Pharmacy Pump.
Device ID | K873875 |
510k Number | K873875 |
Device Name: | BAXA EXACTA-MED PHARMACY PUMP |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-22 |
Decision Date | 1987-11-24 |