The following data is part of a premarket notification filed by Bioeconeer Inc. with the FDA for Ace Monopolar Attachment.
| Device ID | K123061 |
| 510k Number | K123061 |
| Device Name: | ACE MONOPOLAR ATTACHMENT |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BIOECONEER INC. NO. 45, MINSHENG RD. DANSHUI DIST. New Taipei City, TW 251 |
| Contact | Michael Lee |
| Correspondent | Michael Lee BIOECONEER INC. NO. 45, MINSHENG RD. DANSHUI DIST. New Taipei City, TW 251 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-08-13 |
| Summary: | summary |