The following data is part of a premarket notification filed by Foshan Nanhai Plus Medical Co., Ltd. with the FDA for Plus Surgical Gowns (eo Sterilized), Pmgb-xxx.
| Device ID | K133075 |
| 510k Number | K133075 |
| Device Name: | Plus Surgical Gowns (EO Sterilized), PMGB-XXX |
| Classification | Gown, Surgical |
| Applicant | FOSHAN NANHAI PLUS MEDICAL CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Leon Lu |
| Correspondent | Leon Lu FOSHAN NANHAI PLUS MEDICAL CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2015-06-24 |