PROCEDURE REHEARSAL STUDIO
System, Image Processing, Radiological
SIMBIONIX LTD.
The following data is part of a premarket notification filed by Simbionix Ltd. with the FDA for Procedure Rehearsal Studio.
Pre-market Notification Details
| Device ID | K093269 |
| 510k Number | K093269 |
| Device Name: | PROCEDURE REHEARSAL STUDIO |
| Classification | System, Image Processing, Radiological |
| Applicant | SIMBIONIX LTD. 1914 J N PEASE PL. Charlotte, NC 28262 |
| Contact | Shoshana Friedman |
| Correspondent | Shoshana Friedman SIMBIONIX LTD. 1914 J N PEASE PL. Charlotte, NC 28262 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-19 |
| Decision Date | 2010-08-20 |
| Summary: | summary |
Trademark Results [PROCEDURE REHEARSAL STUDIO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROCEDURE REHEARSAL STUDIO 77566372 3797749 Live/Registered |
3D SYSTEMS, INC. 2008-09-10 |
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