The following data is part of a premarket notification filed by Azur Medical Company Inc. with the FDA for Sterile Hypodermic Needles For Single Use.
| Device ID | K211214 |
| 510k Number | K211214 |
| Device Name: | Sterile Hypodermic Needles For Single Use |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Azur Medical Company Inc. 6710 Everglades Dr. Richmond, VA 23838 |
| Contact | Di Zhao |
| Correspondent | Di Zhao Azur Medical Company Inc. 6710 Everglades Dr. Richmond, VA 23838 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-23 |
| Decision Date | 2021-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860010450123 | K211214 | 000 |
| 00860010450116 | K211214 | 000 |
| 00860010450109 | K211214 | 000 |