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 |