The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Acustar I Advanced Surgical Navigation System.
Device ID | K944612 |
510k Number | K944612 |
Device Name: | ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM |
Classification | System, Image Processing, Radiological |
Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Sally L Maher |
Correspondent | Sally L Maher Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-19 |
Decision Date | 1995-12-11 |