510(k) K220794

Device
Error Temporarily Unavailable Please Select Your Back Button Or Choose A Page Listed Below. Thank You.
Applicant
Error Temporarily Unavailable Please Select Your Back Button Or Choose A Page Listed Below. Thank You.
510(k) number
K220794
Product code
ERROR TEMPORARILY UNAVAILABLE PLEASE SELECT YOUR BACK BUTTON OR CHOOSE A PAGE LISTED BELOW. THANK YOU.
Decision
Error Temporarily Unavailable Please Select Your Back Button Or Choose A Page Listed Below. Thank You. (SESE)
Decision date
2022-11-10
Date received
2022-03-18
Regulation
Error Temporarily Unavailable
Classification name
Error Temporarily Unavailable Please Select Your Back Button Or Choose A Page Listed Below. Thank You.
Medical specialty
Error Temporarily Unavailable Please Select Your Back Button Or Choose A Page Listed Below. Thank You.
Review panel
Error Temporarily Unavailable Please Select Your Back Button Or Choose A Page Listed Below. Thank You.
Device class
2
Clearance type
Error Temporari
Statement or summary
Summary
Third party reviewed
Error Temporarily Unavailable Please Select Your Back Button Or Choose A Page Listed Below. Thank You.

Applicant Contact#

Contact
Lee Dong Gun
Address
3f Hyungkyung Bldg., 611, Seolleung-Ro Gangnam-Gu KR 06103 06103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF