The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Subarachnoid Screw, Model No.1350-2.
| Device ID | K883115 |
| 510k Number | K883115 |
| Device Name: | PMT SUBARACHNOID SCREW, MODEL NO.1350-2 |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Contact | Al Iversen |
| Correspondent | Al Iversen PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-25 |
| Decision Date | 1988-08-29 |