The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Hakim Programmable Valve W/wo Siphonguard.
| Device ID | K053107 |
| 510k Number | K053107 |
| Device Name: | CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Susan Kagan |
| Correspondent | Susan Kagan 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 | 2005-11-04 |
| Decision Date | 2006-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704041474 | K053107 | 000 |
| 10381780519829 | K053107 | 000 |
| 10381780519171 | K053107 | 000 |
| 10381780519218 | K053107 | 000 |
| 10886704041399 | K053107 | 000 |
| 10886704041481 | K053107 | 000 |
| 10886704041498 | K053107 | 000 |
| 10886704041528 | K053107 | 000 |
| 10886704041535 | K053107 | 000 |
| 10886704041542 | K053107 | 000 |
| 10886704041825 | K053107 | 000 |
| 10886704041832 | K053107 | 000 |
| 10886704041849 | K053107 | 000 |
| 10886704041856 | K053107 | 000 |
| 10886704041863 | K053107 | 000 |
| 10381780515647 | K053107 | 000 |
| 10381780519164 | K053107 | 000 |