The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Fiducial Marker System.
| Device ID | K953568 |
| 510k Number | K953568 |
| Device Name: | CODMAN FIDUCIAL MARKER SYSTEM |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Sigi Caron |
| Correspondent | Sigi Caron Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-31 |
| Decision Date | 1996-02-29 |