The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Syringe.
| Device ID | K191359 |
| 510k Number | K191359 |
| Device Name: | Nipro 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 | 2019-05-21 |
| Decision Date | 2019-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10383790006993 | K191359 | 000 |
| 10383790007266 | K191359 | 000 |
| 10383790007259 | K191359 | 000 |
| 10383790007242 | K191359 | 000 |
| 10383790007235 | K191359 | 000 |
| 10383790007228 | K191359 | 000 |
| 10383790007211 | K191359 | 000 |
| 10383790007204 | K191359 | 000 |
| 10383790007198 | K191359 | 000 |
| 10383790007181 | K191359 | 000 |
| 10383790007174 | K191359 | 000 |
| 10383790007273 | K191359 | 000 |
| 10383790007280 | K191359 | 000 |
| 10383790007297 | K191359 | 000 |
| 10383790006979 | K191359 | 000 |
| 10383790006962 | K191359 | 000 |
| 10383790006931 | K191359 | 000 |
| 10383790007365 | K191359 | 000 |
| 10383790007358 | K191359 | 000 |
| 10383790007341 | K191359 | 000 |
| 10383790007334 | K191359 | 000 |
| 10383790007327 | K191359 | 000 |
| 10383790007310 | K191359 | 000 |
| 10383790007303 | K191359 | 000 |
| 10383790007006 | K191359 | 000 |