The following data is part of a premarket notification filed by Surgical Theater, Llc with the FDA for Surgery Rehearsal Platform.
| Device ID | K123023 |
| 510k Number | K123023 |
| Device Name: | SURGERY REHEARSAL PLATFORM |
| Classification | System, Image Processing, Radiological |
| Applicant | SURGICAL THEATER, LLC 151 INNOVATION DR. Elyria, OH 44141 |
| Contact | Mordechai Avisar |
| Correspondent | Mordechai Avisar SURGICAL THEATER, LLC 151 INNOVATION DR. Elyria, OH 44141 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863157000350 | K123023 | 000 |
| 00863157000343 | K123023 | 000 |
| 00863157000336 | K123023 | 000 |