The following data is part of a premarket notification filed by China Nantong Guangda Textile Co., Ltd. with the FDA for Operating Room Towel, Sterile, Colors Blue Or White.
| Device ID | K001858 |
| 510k Number | K001858 |
| Device Name: | OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE |
| Classification | Drape, Surgical |
| Applicant | CHINA NANTONG GUANGDA TEXTILE CO., LTD. 1532 LONGMEADOW RD. Bartlett, IL 60103 |
| Contact | Yong Zhang |
| Correspondent | Yong Zhang CHINA NANTONG GUANGDA TEXTILE CO., LTD. 1532 LONGMEADOW RD. Bartlett, IL 60103 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-19 |
| Decision Date | 2000-08-17 |