The following data is part of a premarket notification filed by Baxa Corp., Sub. Of Cook Group, Inc. with the FDA for Cytosafe Needle.
Device ID | K844904 |
510k Number | K844904 |
Device Name: | CYTOSAFE NEEDLE |
Classification | Set, I.v. Fluid Transfer |
Applicant | BAXA CORP., SUB. OF COOK GROUP, INC. P.O. BOX 9327 Denver, CO 80209 |
Contact | Mary Steggall |
Correspondent | Mary Steggall BAXA CORP., SUB. OF COOK GROUP, INC. P.O. BOX 9327 Denver, CO 80209 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-17 |
Decision Date | 1985-02-22 |