The following data is part of a premarket notification filed by China National Medicines & Health Prod. I/e Corp. with the FDA for White Plume Surgical Gauze Face Mask.
| Device ID | K870312 |
| 510k Number | K870312 |
| Device Name: | WHITE PLUME SURGICAL GAUZE FACE MASK |
| Classification | Mask, Surgical |
| Applicant | CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. C/O PACIFIC DEVELOPMENT GROUP 1000 T. JEFFERSON ST NW Suite 500, Washington, DC 20007 |
| Contact | Lisa Mitnick |
| Correspondent | Lisa Mitnick CHINA NATIONAL MEDICINES & HEALTH PROD. I/E CORP. C/O PACIFIC DEVELOPMENT GROUP 1000 T. JEFFERSON ST NW Suite 500, Washington, DC 20007 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-28 |
| Decision Date | 1987-02-24 |