The following data is part of a premarket notification filed by Tiger Medical Products Ltd with the FDA for Tiger Flat Surgical Mask.
| Device ID | K102713 |
| 510k Number | K102713 |
| Device Name: | TIGER FLAT SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | TIGER MEDICAL PRODUCTS LTD LIULIN TOWER, STE 1910, 1 HUAI HAI ZHONG ROAD Shanghai, CN 200021 |
| Contact | Maggie Zhong |
| Correspondent | Maggie Zhong TIGER MEDICAL PRODUCTS LTD LIULIN TOWER, STE 1910, 1 HUAI HAI ZHONG ROAD Shanghai, CN 200021 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-20 |
| Decision Date | 2011-01-25 |
| Summary: | summary |