The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Epix Electrosurgical Probe Spatula Tip, Epix Electrosurgical Probe L-hook Tip, Epix Electrosurgical Probe J-hook Tip, Re.
| Device ID | K132300 |
| 510k Number | K132300 |
| Device Name: | EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Jessica Cho |
| Correspondent | Jessica Cho APPLIED MEDICAL RESOURCES CORP. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-24 |
| Decision Date | 2014-01-24 |
| Summary: | summary |