Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K201063 |
Device Name |
DANNIK Disposable Monopolar Laparoscopic Instrument |
Applicant |
Dannik |
941 W Morse Blvd. Suite 100 |
Winter Park,
FL
32789
|
|
Applicant Contact |
Olga Haberlad |
Correspondent |
Dannik |
941 W Morse Blvd. Suite 100 |
Winter Park,
FL
32789
|
|
Correspondent Contact |
Olga Haberland |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 04/21/2020 |
Decision Date | 06/09/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|