The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt External External Drainage System (eds).
| Device ID | K935560 |
| 510k Number | K935560 |
| Device Name: | PMT EXTERNAL EXTERNAL DRAINAGE SYSTEM (EDS) |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PMT CORP. 1500 PARK RD. P.O. BOX 610 Chanhassen, MN 55317 |
| Contact | Mark Pace |
| Correspondent | Mark Pace PMT CORP. 1500 PARK RD. P.O. BOX 610 Chanhassen, MN 55317 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-17 |
| Decision Date | 1994-11-07 |