The following data is part of a premarket notification filed by Sentinelle Medical, Inc. with the FDA for Aegis Navigation Anda Egis Pelvic Application.
| Device ID | K093672 |
| 510k Number | K093672 |
| Device Name: | AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION |
| Classification | System, Image Processing, Radiological |
| Applicant | SENTINELLE MEDICAL, INC. 555 RICHMOND STREET W SUITE 800, PO BOX 301 Toronto, Ontario, CA M5v 3b1 |
| Contact | Joan Medley |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-27 |
| Decision Date | 2009-12-11 |
| Summary: | summary |