The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Syringe.
Device ID | K173029 |
510k Number | K173029 |
Device Name: | Nipro Syringe |
Classification | Syringe, Piston |
Applicant | Nipro Medical Corporation 3150 NW 107th Ave. Miami, FL 33172 |
Contact | Jessica Oswald-mcleod |
Correspondent | Jessica Oswald-mcleod Nipro Medical Corporation 3150 NW 107th Ave. Miami, 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 | 2017-09-28 |
Decision Date | 2018-03-30 |
Summary: | summary |