The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for Iv Extension Set.
Device ID | K875186 |
510k Number | K875186 |
Device Name: | IV EXTENSION SET |
Classification | Tubing, Fluid Delivery |
Applicant | MARQUETTE MEDICAL, INC. 2134 ESPEY CT. #7 Crofton, MD 21114 |
Contact | Marquette Jr |
Correspondent | Marquette Jr MARQUETTE MEDICAL, INC. 2134 ESPEY CT. #7 Crofton, MD 21114 |
Product Code | FPK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-22 |
Decision Date | 1988-02-16 |