The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for Winged Non-coring Needle Set.
| Device ID | K884212 |
| 510k Number | K884212 |
| Device Name: | WINGED NON-CORING NEEDLE SET |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MARQUETTE MEDICAL, INC. 2134 ESPEY CT. #7 Crofton, MD 21114 |
| Contact | Earl D Marquette,jr |
| Correspondent | Earl D Marquette,jr MARQUETTE MEDICAL, INC. 2134 ESPEY CT. #7 Crofton, MD 21114 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1988-10-17 |