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 |