The following data is part of a premarket notification filed by Beijing Hangtian Kadi Technology R&d Institute with the FDA for Specimen Retrieval Bag.
| Device ID | K172789 |
| 510k Number | K172789 |
| Device Name: | Specimen Retrieval Bag |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | Beijing HangTian KaDi Technology R&D Institute Room301-11, Third Floor, Building No.13, No.15 Jing Sheng Nan Er Street Beijing, CN 101102 |
| Contact | Liying Zhang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-15 |
| Decision Date | 2018-02-01 |
| Summary: | summary |