The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Tubing Sets For Baxa Exacta-med Pharmacy Pump.
Device ID | K900585 |
510k Number | K900585 |
Device Name: | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP |
Classification | Set, I.v. Fluid Transfer |
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 | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-07 |
Decision Date | 1990-04-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412480072 | K900585 | 000 |
50085412475726 | K900585 | 000 |
50085412476525 | K900585 | 000 |
50085412476549 | K900585 | 000 |
50085412476556 | K900585 | 000 |
50085412476709 | K900585 | 000 |
50085412476860 | K900585 | 000 |
50085412477003 | K900585 | 000 |
50085412477201 | K900585 | 000 |
50085412477218 | K900585 | 000 |
50085412477225 | K900585 | 000 |
50085412477232 | K900585 | 000 |
50085412477249 | K900585 | 000 |
50085412477256 | K900585 | 000 |
50085412477263 | K900585 | 000 |
50085412477270 | K900585 | 000 |
55413765482590 | K900585 | 000 |