The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Modification To Hakim Precision Valve System, Hakim Programmable Valve System, Hakim Micro Programmable Valve System, Si.
| Device ID | K041296 |
| 510k Number | K041296 |
| Device Name: | MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Kathryn Wunder |
| Correspondent | Kathryn Wunder 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 | 2004-05-14 |
| Decision Date | 2004-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704042143 | K041296 | 000 |
| 10886704041559 | K041296 | 000 |
| 10886704041566 | K041296 | 000 |
| 10886704041573 | K041296 | 000 |
| 10886704041580 | K041296 | 000 |
| 10381780520108 | K041296 | 000 |
| 10886704042013 | K041296 | 000 |
| 10381780520122 | K041296 | 000 |
| 10886704042037 | K041296 | 000 |
| 10381780520146 | K041296 | 000 |
| 10381780520207 | K041296 | 000 |
| 10381780520214 | K041296 | 000 |
| 10381780520221 | K041296 | 000 |
| 10381780520238 | K041296 | 000 |
| 10886704041511 | K041296 | 000 |