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 | K061876 |
| 510k Number | K061876 |
| Device Name: | CODMAN VPV SYSTEM, MODEL 82-3192 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DRIVE Raynham, MA 02767 -3050 |
| Contact | Susan Kagan |
| Correspondent | Susan Kagan Codman & Shurtleff, Inc. 325 PARAMOUNT DRIVE Raynham, MA 02767 -3050 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2006-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780519348 | K061876 | 000 |
| 10886704078609 | K061876 | 000 |