The following data is part of a premarket notification filed by China Surgical Dressings Center Co.,ltd with the FDA for Surgical Face Mask.
| Device ID | K050689 |
| 510k Number | K050689 |
| Device Name: | SURGICAL FACE MASK |
| Classification | Mask, Surgical |
| Applicant | CHINA SURGICAL DRESSINGS CENTER CO.,LTD 4 F. 232 JEN AI RD., SEC. 4 Taipei, Taiwan, TW |
| Contact | Michael F. L Chang |
| Correspondent | Michael F. L Chang CHINA SURGICAL DRESSINGS CENTER CO.,LTD 4 F. 232 JEN AI RD., SEC. 4 Taipei, Taiwan, TW |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-17 |
| Decision Date | 2005-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00000000001908 | K050689 | 000 |