The following data is part of a premarket notification filed by Wickimed(huizhou)medical Equipment Manufacturing Co.,ltd. with the FDA for Equipment Pouch.
| Device ID | K172578 |
| 510k Number | K172578 |
| Device Name: | Equipment Pouch |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. Tang Jiao Xing Wang Street, Lilin Town Zhongkai Hi-Tech Zone Huizhou, CN 516000 |
| Contact | Haobin Li |
| Correspondent | Haobin Li WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. Tang Jiao Xing Wang Street, Lilin Town Zhongkai Hi-Tech Zone Huizhou, CN 516000 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-28 |
| Decision Date | 2017-12-07 |
| Summary: | summary |