510(k) K110342

YOLO CURVE by Yolo Medical, Inc. — Product Code ILY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2011
Date Received
February 4, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Infrared, Therapeutic Heating
Device Class
Class II
Regulation Number
890.5500
Review Panel
PM
Submission Type