The following data is part of a premarket notification filed by Promedical Products Co., Ltd. with the FDA for Promedical Surgical Gowns, Models: 1002494a, 100770a.
| Device ID | K080627 |
| 510k Number | K080627 |
| Device Name: | PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A |
| Classification | Gown, Surgical |
| Applicant | PROMEDICAL PRODUCTS CO., LTD. # 206 HAUNG HE ROAD WEST Changzhou, Jiangsu, CN 213022 |
| Contact | Leo Wei |
| Correspondent | Leo Wei PROMEDICAL PRODUCTS CO., LTD. # 206 HAUNG HE ROAD WEST Changzhou, Jiangsu, CN 213022 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-05 |
| Decision Date | 2008-04-24 |