The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Hakim Programmer And Transmitter.
| Device ID | K003564 |
| 510k Number | K003564 |
| Device Name: | HAKIM PROGRAMMER AND TRANSMITTER |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Laura O'grady |
| Correspondent | Laura O'grady 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 | 2000-11-20 |
| Decision Date | 2000-12-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780519317 | K003564 | 000 |
| 10886704078616 | K003564 | 000 |
| 10886704041597 | K003564 | 000 |