Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K221523
Device Classification Name
Booth, Sun Tan
More FDA Info for this Device
510(K) Number
K221523
Device Name
Booth, Sun Tan
Applicant
Unilam Co., Ltd.
23 Samdong-Ro, Samnam-Myeon, Ulju-Gun, Ulsan
Ulsan Gwangyeogsi 44954 KR
Other 510(k) Applications for this Company
Contact
Y B Cho
Other 510(k) Applications for this Contact
Regulation Number
878.4635
More FDA Info for this Regulation Number
Classification Product Code
LEJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/26/2022
Decision Date
02/15/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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