The following data is part of a premarket notification filed by Medtronic Ps Medical with the FDA for Medtronic Ps Medical Polyurethane Shunt, Models 27521, 27116, 20022.
| Device ID | K991502 |
| 510k Number | K991502 |
| Device Name: | MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC PS MEDICAL 125 CREMONA DR. Goleta, CA 93117 -5500 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-29 |
| Decision Date | 2000-09-12 |
| Summary: | summary |