The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Tissue Containment System; 10, 14, 17, 25.
| Device ID | K142427 |
| 510k Number | K142427 |
| Device Name: | TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Aeree Lee |
| Correspondent | Aeree Lee APPLIED MEDICAL RESOURCES 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 | 2014-08-29 |
| Decision Date | 2014-12-23 |
| Summary: | summary |