The following data is part of a premarket notification filed by Applied Medical Resources Corporation with the FDA for Applied Medical Laparoscopic Linear Cutter.
| Device ID | K190331 |
| 510k Number | K190331 |
| Device Name: | Applied Medical Laparoscopic Linear Cutter |
| Classification | Staple, Implantable |
| Applicant | Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Aditi Iyengar |
| Correspondent | Aditi Iyengar Applied Medical Resources Corporation 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-11-22 |