Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K231126 |
Device Name |
Eblator Device |
Applicant |
E Surgical, LLC |
150 Isidor Court Unit 203 |
Sparks,
NV
89441
|
|
Applicant Contact |
Michael Blomeyer |
Correspondent |
Coombs Medical Device Consulting, Inc |
1100 Pacific Marina, Suite 806 |
Alameda,
CA
94501
|
|
Correspondent Contact |
Craig J Coombs |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/20/2023 |
Decision Date | 08/02/2023 |
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
|
|
|