Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K232508
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K232508
Device Name
System, Thermal Regulating
Applicant
Molnlycke Health Care US, LLC
5445 Triangle Parkway, Suite 400
Peachtree Corners, GA 30092 US
Other 510(k) Applications for this Company
Contact
Megan Bevill
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
08/18/2023
Decision Date
09/15/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact