Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K192643 |
Device Name |
Dannik Laparoscopic Suction Irrigation System |
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 | 876.1500
|
Classification Product Code |
|
Date Received | 09/24/2019 |
Decision Date | 11/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|