The following data is part of a premarket notification filed by Ingenjorsfirman Bjorn Bergdahl Ab with the FDA for Coa-comp/m, Automated Bipolar Coagulator.
| Device ID | K023733 |
| 510k Number | K023733 |
| Device Name: | COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | INGENJORSFIRMAN BJORN BERGDAHL AB HALLESAS 6452 Billdal, SE Se 427 51 |
| Contact | Bjorn Bergdahl |
| Correspondent | Bjorn Bergdahl INGENJORSFIRMAN BJORN BERGDAHL AB HALLESAS 6452 Billdal, SE Se 427 51 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-06 |
| Decision Date | 2003-05-14 |
| Summary: | summary |