Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K152266
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K152266
Device Name
System, Thermal Regulating
Applicant
STRYKER MEDICAL
3800 EAST CENTRE AVENUE
PORTAGE, MI 49002 US
Other 510(k) Applications for this Company
Contact
BRIAN ORWAT
Other 510(k) Applications for this Contact
Regulation Number
870.5900
More FDA Info for this Regulation Number
Classification Product Code
DWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/11/2015
Decision Date
12/02/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact