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FDA 510(k) Application Details - K053254
Device Classification Name
Infant Heel Warmer (Chemical Heat Pack)
More FDA Info for this Device
510(K) Number
K053254
Device Name
Infant Heel Warmer (Chemical Heat Pack)
Applicant
SHANGHAI INTCO MEDICAL SUPPLY CO., LTD.
12390 EAST END AVENUE
CHINO, CA 91710 US
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Contact
JOHN ZHAO
Other 510(k) Applications for this Contact
Regulation Number
890.5710
More FDA Info for this Regulation Number
Classification Product Code
MPO
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More FDA Info for this Product Code
Date Received
11/21/2005
Decision Date
09/19/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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