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 |