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FDA 510(k) Application Details - K131259
Device Classification Name
Lamp, Infrared, Therapeutic Heating
More FDA Info for this Device
510(K) Number
K131259
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
XILIXIAOBAIMANG
SHENZHEN, GUANGDONG 518108 CN
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Contact
JIANGPING KANG
Other 510(k) Applications for this Contact
Regulation Number
890.5500
More FDA Info for this Regulation Number
Classification Product Code
ILY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/02/2013
Decision Date
12/27/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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