The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Abont Syringe.
Device ID | K212677 |
510k Number | K212677 |
Device Name: | AboNT SYRINGE |
Classification | Syringe, Piston |
Applicant | Nipro Medical Corporation 3150 NW 107th Ave Doral, FL 33172 |
Contact | Jessica Oswald-mcleod |
Correspondent | Jessica Oswald-mcleod Nipro Medical Corporation 3150 NW 107th Ave Doral, FL 33172 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-24 |
Decision Date | 2022-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ABONT SYRINGE 79305222 not registered Live/Pending |
Galderma S.A. 2021-01-09 |