The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Hakim Programmable And Precision Valve Shunt System.
| Device ID | K122118 |
| 510k Number | K122118 |
| Device Name: | HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Kathy Strange |
| Correspondent | Kathy Strange 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 | 2012-07-17 |
| Decision Date | 2012-08-03 |
| Summary: | summary |