The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Spetzler Mankind Ventriculostomy External 1114-1.
| Device ID | K883114 |
| 510k Number | K883114 |
| Device Name: | SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Contact | Alfred Iversen |
| Correspondent | Alfred Iversen PMT CORP. 1500 PARK RD. 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 | 1988-07-25 |
| Decision Date | 1988-08-24 |