Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K152803
Device Classification Name
Syringe, Piston
More FDA Info for this Device
510(K) Number
K152803
Device Name
Syringe, Piston
Applicant
SUNG SHIM MEDICARE CO., LTD.
190, MAESIL-RO
SOJEONG-MYEON
SEJONG-SI 30002 KR
Other 510(k) Applications for this Company
Contact
KIM YOUNG KWAN
Other 510(k) Applications for this Contact
Regulation Number
880.5860
More FDA Info for this Regulation Number
Classification Product Code
FMF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/28/2015
Decision Date
07/12/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact