The following data is part of a premarket notification filed by Lccs Products Limited with the FDA for Anesthesia Conduction Needles.
Device ID | K131006 |
510k Number | K131006 |
Device Name: | ANESTHESIA CONDUCTION NEEDLES |
Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
Applicant | LCCS PRODUCTS LIMITED 7TH FLOOR, JINGGUI BUSINESS BUILDING, NO. 982 CONGYUN RD., BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
Contact | Mike Gu |
Correspondent | Mike Gu LCCS PRODUCTS LIMITED 7TH FLOOR, JINGGUI BUSINESS BUILDING, NO. 982 CONGYUN RD., BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
Product Code | BSP |
CFR Regulation Number | 868.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-11 |
Decision Date | 2013-12-06 |
Summary: | summary |