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 |