The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for Iv Bifurcated Extension Set.
Device ID | K900426 |
510k Number | K900426 |
Device Name: | IV BIFURCATED EXTENSION SET |
Classification | Set, Administration, Intravascular |
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 | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-30 |
Decision Date | 1990-02-28 |