The following data is part of a premarket notification filed by Cathay Manufacturing Corp. with the FDA for Disposable Neutral Electrode Gp202.
| Device ID | K130027 |
| 510k Number | K130027 |
| Device Name: | DISPOSABLE NEUTRAL ELECTRODE GP202 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CATHAY MANUFACTURING CORP. NO. 328, XISHE ROAD, MAOGANG TOWN, SONGJIANG AREA Shanghai, CN 201607 |
| Contact | Zhang Hui |
| Correspondent | Zhang Hui CATHAY MANUFACTURING CORP. NO. 328, XISHE ROAD, MAOGANG TOWN, SONGJIANG AREA Shanghai, CN 201607 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-03 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30749756886858 | K130027 | 000 |
| 16959006300397 | K130027 | 000 |
| 16959006303299 | K130027 | 000 |
| 16959006304418 | K130027 | 000 |
| 16959006304401 | K130027 | 000 |
| 16959006300823 | K130027 | 000 |
| 16959006300816 | K130027 | 000 |
| 16959006300786 | K130027 | 000 |
| 16959006300779 | K130027 | 000 |
| 16959006300502 | K130027 | 000 |
| 16959006303268 | K130027 | 000 |
| 06959006300208 | K130027 | 000 |
| 06959006300222 | K130027 | 000 |
| 30749756878136 | K130027 | 000 |
| 50749756878123 | K130027 | 000 |
| 50749756878116 | K130027 | 000 |
| 30749756878082 | K130027 | 000 |
| 50749756878079 | K130027 | 000 |
| 50749756126415 | K130027 | 000 |
| 30749756053298 | K130027 | 000 |
| 06959006300680 | K130027 | 000 |
| 06959006300673 | K130027 | 000 |
| 06959006300499 | K130027 | 000 |