The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman External Drainage System Ii (eds Ii).
| Device ID | K910938 |
| 510k Number | K910938 |
| Device Name: | CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Jeanette G Cloutier |
| Correspondent | Jeanette G Cloutier Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-06 |
| Decision Date | 1991-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886704066443 | K910938 | 000 |
| 10886704040873 | K910938 | 000 |
| 10886704040804 | K910938 | 000 |
| 20886704040795 | K910938 | 000 |
| 20886704000508 | K910938 | 000 |