The following data is part of a premarket notification filed by Afs Medical Co. Ltd. with the FDA for Afs Medical Sterile Single-use Access Port System.
Device ID | K202688 |
510k Number | K202688 |
Device Name: | AFS Medical Sterile Single-Use Access Port System |
Classification | Laparoscopic Single Port Access Device |
Applicant | AFS Medical Co. Ltd. Na-131, Ezen Mecha Zone, 117 Hwanggeum-ro, Yangchon-eup, Gimpo-si Gyeonggi-do, KR 10048 |
Contact | Min Ah Kim |
Correspondent | Michele Lucey Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, NH 03255 |
Product Code | OTJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-15 |
Decision Date | 2021-10-14 |