PROcedure Rehearsal Studio
System, Image Processing, Radiological
3DSYSTEMS, SIMBIONIX PRODUCTS
The following data is part of a premarket notification filed by 3dsystems, Simbionix Products with the FDA for Procedure Rehearsal Studio.
Pre-market Notification Details
| Device ID | K153705 |
| 510k Number | K153705 |
| Device Name: | PROcedure Rehearsal Studio |
| Classification | System, Image Processing, Radiological |
| Applicant | 3DSYSTEMS, SIMBIONIX PRODUCTS BEIT GOLAN CORNER OF GOLAN AND HANEGEV ST. Airport City, IL 70151 |
| Contact | Kim Torluemke |
| Correspondent | Kim Torluemke 3D SYSTEMS, INC. 5381 South Alkire Circle Littleton, CO 80127 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2016-09-02 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816847021371 | K153705 | 000 |
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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