The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Eds3 Csf External Drainage System.
| Device ID | K162437 |
| 510k Number | K162437 |
| Device Name: | Codman EDS3 CSF External Drainage System |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Christopher Garete |
| Correspondent | Christopher Garete Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-31 |
| Decision Date | 2016-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830050593 | K162437 | 000 |
| 00382830050555 | K162437 | 000 |
| 00382830050548 | K162437 | 000 |