Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K223932 |
Device Name |
SafeAir combi (SFR-combi-US) |
Applicant |
LiNA Medical ApS |
Formervangen 5 |
Glostrup,
DK
DK-2600
|
|
Applicant Contact |
Jaroslaw Mrowczynski |
Correspondent |
MEDIcept. Inc. |
200 Homer Ave |
Ashland,
MA
01721
|
|
Correspondent Contact |
Scott Blood |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/30/2022 |
Decision Date | 04/26/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|