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 Pencils, Models: Obs-db, Obs-dr, Obs-df.
| Device ID | K092634 |
| 510k Number | K092634 |
| Device Name: | OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF |
| 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 Guang Dong, CN 529100 |
| Contact | Chen Xi |
| Correspondent | Jay Kogoma 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 | 2009-08-27 |
| Decision Date | 2009-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G373SEP2A0 | K092634 | 000 |
| G3731420010 | K092634 | 000 |
| G3731425100 | K092634 | 000 |
| G3731420120 | K092634 | 000 |
| G3731415080 | K092634 | 000 |
| G3731400030 | K092634 | 000 |