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 |