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 |