The following data is part of a premarket notification filed by Azur Medical Company Inc. with the FDA for Sterile Syringes For Single Use With/without Needle.
Device ID | K211211 |
510k Number | K211211 |
Device Name: | Sterile Syringes For Single Use With/without Needle |
Classification | Syringe, Piston |
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 | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-04-23 |
Decision Date | 2021-10-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860010450192 | K211211 | 000 |
00860010450185 | K211211 | 000 |
00860010450178 | K211211 | 000 |
00860010450161 | K211211 | 000 |
00860010450154 | K211211 | 000 |
00860010450147 | K211211 | 000 |
00860010450130 | K211211 | 000 |