The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Pmt Mankind Lumbar-peritoneal Shunt Model 1115-1.
| Device ID | K881616 |
| 510k Number | K881616 |
| Device Name: | PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PROGRESS MANKIND TECHNOLOGY BOX 484 Chanhassen, MN 55317 |
| Contact | Alfred A Iversen |
| Correspondent | Alfred A Iversen PROGRESS MANKIND TECHNOLOGY BOX 484 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 | 1988-04-12 |
| Decision Date | 1988-09-09 |