The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Chemo Dispensing Pin, Model 12495.
Device ID | K024239 |
510k Number | K024239 |
Device Name: | CHEMO DISPENSING PIN, MODEL 12495 |
Classification | Set, I.v. Fluid Transfer |
Applicant | ABBOTT LABORATORIES DEPT 0389 BLDG J-45 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6133 |
Contact | Nicohl R Wilding |
Correspondent | Nicohl R Wilding ABBOTT LABORATORIES DEPT 0389 BLDG J-45 200 ABBOTT PARK ROAD Abbott Park, IL 60064 -6133 |
Product Code | LHI |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-23 |
Decision Date | 2003-01-13 |