The following data is part of a premarket notification filed by Marquette Medical, Inc. with the FDA for Straight And Right Angle Non-coring Needles.
| Device ID | K884211 |
| 510k Number | K884211 |
| Device Name: | STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10812608020031 | K884211 | 000 |
| 10812608020024 | K884211 | 000 |
| 10812608020017 | K884211 | 000 |
| 10812608020000 | K884211 | 000 |