The following data is part of a premarket notification filed by Lccs Products Limited with the FDA for Single Use Grounding Pad.
Device ID | K132136 |
510k Number | K132136 |
Device Name: | SINGLE USE GROUNDING PAD |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | LCCS PRODUCTS LIMITED 7TH FL, JINGGUI BUSINESS BLDG, NO. 982 CONGYUN RD., BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-11 |
Decision Date | 2013-09-06 |
Summary: | summary |