The following data is part of a premarket notification filed by Pressure Products Medical Device Manufacturing Llc with the FDA for Safesept Blunt Needle.
| Device ID | K210328 |
| 510k Number | K210328 |
| Device Name: | SafeSept Blunt Needle |
| Classification | Trocar |
| Applicant | Pressure Products Medical Device Manufacturing LLC 1 School Street Morton, PA 19070 |
| Contact | Andrew Amour |
| Correspondent | Andrew Amour Pressure Products Medical Device Manufacturing LLC 1 School Street Morton, PA 19070 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-04 |
| Decision Date | 2021-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30858769006402 | K210328 | 000 |
| 30858769006396 | K210328 | 000 |
| 30858769006389 | K210328 | 000 |
| 30858769006372 | K210328 | 000 |
| 30858769006365 | K210328 | 000 |
| 00858769006357 | K210328 | 000 |