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FDA 510(k) Application Details - K121487
Device Classification Name
Lamp, Infrared, Therapeutic Heating
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510(K) Number
K121487
Device Name
Lamp, Infrared, Therapeutic Heating
Applicant
LITECURE, LLC
250 Corporate Blvd.
Suite B
NEWARK, DE 19702 US
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Contact
LIANG LU
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Regulation Number
890.5500
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Classification Product Code
ILY
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More FDA Info for this Product Code
Date Received
05/18/2012
Decision Date
06/12/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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