Device Classification Name |
Laparoscopic Single Port Access Device
|
510(k) Number |
K232062 |
Device Name |
Uni-port |
Applicant |
Dalim Medical Corp. |
102-606 and 609(Ho), 397, Seokcheon-ro |
Bucheon-si,
KR
14449
|
|
Applicant Contact |
Ji Hoon Eom |
Correspondent |
Dalim Medical Corp. |
102-606 and 609(Ho), 397, Seokcheon-ro |
Bucheon-si,
KR
14449
|
|
Correspondent Contact |
Dave Kim |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/11/2023 |
Decision Date | 01/16/2024 |
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
|
|
|