Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K202688
Device Classification Name
More FDA Info for this Device
510(K) Number
K202688
Device Name
AFS Medical Sterile Single-Use Access Port System
Applicant
AFS Medical Co. Ltd.
Na-131, Ezen Mecha Zone, 117 Hwanggeum-ro,
Yangchon-eup, Gimpo-si
Gyeonggi-do 10048 KR
Other 510(k) Applications for this Company
Contact
Min Ah Kim
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OTJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/15/2020
Decision Date
10/14/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact