The following data is part of a premarket notification filed by Applied Medical Resources Corp. with the FDA for Dissecting Balloon System.
| Device ID | K182024 |
| 510k Number | K182024 |
| Device Name: | Dissecting Balloon System |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Corinne Yestrepsky |
| Correspondent | Corinne Yestrepsky Applied Medical Resources Corp. 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-30 |
| Decision Date | 2018-08-30 |
| Summary: | summary |