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 |