The following data is part of a premarket notification filed by Cathay Manfacturing Corp. with the FDA for Disposable Electrosurgical Pencils.
| Device ID | K170369 |
| 510k Number | K170369 |
| Device Name: | Disposable Electrosurgical Pencils |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Cathay Manfacturing Corp. No.328,Xishe Road,Maogang Town,Songjiang Area Shanghai, CN 201607 |
| Contact | Ren Ren |
| Correspondent | Ren Ren Taizhou EBO Information Technology Co,.Ltd 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 | 2017-02-06 |
| Decision Date | 2018-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16959006302988 | K170369 | 000 |