The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Vpv System, Model 82-3192.
| Device ID | K050739 |
| 510k Number | K050739 |
| Device Name: | CODMAN VPV SYSTEM, MODEL 82-3192 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Karen F Jurczak |
| Correspondent | Karen F Jurczak Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-21 |
| Decision Date | 2005-07-18 |
| Summary: | summary |