The following data is part of a premarket notification filed by Summit International Medical Technologies, Inc. with the FDA for Angel Tip Safety Intravascular Needle Set.
| Device ID | K131950 |
| 510k Number | K131950 |
| Device Name: | ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET |
| Classification | Needle, Fistula |
| Applicant | SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. 7 MEADOW WOOD ROAD Kingston, NH 03848 |
| Contact | Richelle Helman |
| Correspondent | Richelle Helman SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC. 7 MEADOW WOOD ROAD Kingston, NH 03848 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2015-01-16 |
| Summary: | summary |