The following data is part of a premarket notification filed by Navilyst Medical, Inc. with the FDA for Nmi Control Syringe, 7 Ml Nmi Control Syringe, 8 Ml.
| Device ID | K113198 |
| 510k Number | K113198 |
| Device Name: | NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML |
| Classification | Injector And Syringe, Angiographic |
| Applicant | NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Contact | Marion W Gordon |
| Correspondent | Marion W Gordon NAVILYST MEDICAL, INC. 26 FOREST STREET Marlborough, MA 01752 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2011-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10193489066746 | K113198 | 000 |
| 20193489065852 | K113198 | 000 |
| 30193489065880 | K113198 | 000 |
| 30193489065897 | K113198 | 000 |
| 10193489066753 | K113198 | 000 |
| 10193489066760 | K113198 | 000 |
| 10193489066777 | K113198 | 000 |
| 10193489066784 | K113198 | 000 |
| 10193489066791 | K113198 | 000 |
| 10193489066807 | K113198 | 000 |
| 10193489066814 | K113198 | 000 |
| 30193489065842 | K113198 | 000 |