Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K152961
Device Classification Name
Plasma, Coagulation Control
More FDA Info for this Device
510(K) Number
K152961
Device Name
Plasma, Coagulation Control
Applicant
MAINE STANDARDS COMPANY LLC
221 US ROUTE 1
CUMBERLAND FORESIDE, ME 04110 US
Other 510(k) Applications for this Company
Contact
JAMES CHAMPLIN
Other 510(k) Applications for this Contact
Regulation Number
864.5425
More FDA Info for this Regulation Number
Classification Product Code
GGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2015
Decision Date
06/03/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact