The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Fixation Trocars.
| Device ID | K083638 |
| 510k Number | K083638 |
| Device Name: | FIXATION TROCARS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-12-09 |
| Decision Date | 2008-12-23 |
| Summary: | summary |