The following data is part of a premarket notification filed by Tiger Medical Products Ltd with the FDA for Face Mask, Surgical Mask, Procedure Mask, Surgical Face Mask.
| Device ID | K122717 |
| 510k Number | K122717 |
| Device Name: | FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | TIGER MEDICAL PRODUCTS LTD 1 HUAIHAI ZHONG ROAD LIU LIN TOWER, SUITE 1910 Shanghai, CN 200021 |
| Contact | David Wang |
| Correspondent | David Wang TIGER MEDICAL PRODUCTS LTD 1 HUAIHAI ZHONG ROAD LIU LIN TOWER, SUITE 1910 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 | 2012-09-05 |
| Decision Date | 2012-12-21 |
| Summary: | summary |