The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Eds 3 Csf External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738.
| Device ID | K061568 |
| 510k Number | K061568 |
| Device Name: | CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Jocelyn Raposo |
| Correspondent | Jocelyn Raposo Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-06 |
| Decision Date | 2006-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780518372 | K061568 | 000 |
| 00382830050579 | K061568 | 000 |
| 00382830050609 | K061568 | 000 |
| 00382830050616 | K061568 | 000 |
| 10886704040903 | K061568 | 000 |
| 10886704040910 | K061568 | 000 |
| 10886704040934 | K061568 | 000 |
| 10886704040941 | K061568 | 000 |
| 10886704040958 | K061568 | 000 |
| 20886704040924 | K061568 | 000 |
| 00382830050562 | K061568 | 000 |