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 |