The following data is part of a premarket notification filed by Jiangmen City Xinhui Baisheng Medical Equipment Co with the FDA for Obs Disposable Electrosurgical Pads, Monopolar, Biopolar, Models Gbs-dm, Gbs-db.
Device ID | K102372 |
510k Number | K102372 |
Device Name: | OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO BUILDING 1, NO.1, HUIMIN EAST RD HUICHENG TOWN, XINHUI DISTR Jiangmen City, Guangdong, CN 529100 |
Contact | Chen Xi |
Correspondent | William J Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-08-20 |
Decision Date | 2010-11-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10850014433168 | K102372 | 000 |
00817771029013 | K102372 | 000 |
20885632412902 | K102372 | 000 |
20885632412896 | K102372 | 000 |
20885632412889 | K102372 | 000 |