The following data is part of a premarket notification filed by 3l Medical Products Co., Ltd. with the FDA for 3l Surgical Drapes.
| Device ID | K043015 |
| 510k Number | K043015 |
| Device Name: | 3L SURGICAL DRAPES |
| Classification | Drape, Surgical |
| Applicant | 3L MEDICAL PRODUCTS CO., LTD. 1800 CENTURY PARK EAST SUITE 600 Century City, CA 90067 |
| Contact | George Su |
| Correspondent | George Su 3L MEDICAL PRODUCTS CO., LTD. 1800 CENTURY PARK EAST SUITE 600 Century City, CA 90067 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-02 |
| Decision Date | 2005-08-15 |
| Summary: | summary |