The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Ortho Development Orion-i Emf System.
| Device ID | K012129 |
| 510k Number | K012129 |
| Device Name: | ORTHO DEVELOPMENT ORION-I EMF SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Contact | Carol Freasier |
| Correspondent | Michael Kwan UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-07-09 |
| Decision Date | 2001-08-22 |
| Summary: | summary |