The following data is part of a premarket notification filed by Shanghai Neo-medical Import & Export Co., Ltd. with the FDA for Surgical Masks.
| Device ID | K111559 |
| 510k Number | K111559 |
| Device Name: | SURGICAL MASKS |
| Classification | Mask, Surgical |
| Applicant | SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-06 |
| Decision Date | 2011-09-16 |