The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for 4' Low Volume Iv Extension Set.
| Device ID | K905219 |
| 510k Number | K905219 |
| Device Name: | 4' LOW VOLUME IV 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 | 1990-11-20 |
| Decision Date | 1991-06-04 |