The following data is part of a premarket notification filed by Promedical Products Co., Ltd. with the FDA for Promedical Surgical Drapes, Promedical Surgical Mayo Stand Cover, Band Bags.
| Device ID | K080629 |
| 510k Number | K080629 |
| Device Name: | PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS |
| Classification | Drape, 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 | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-05 |
| Decision Date | 2008-10-20 |