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FDA 510(k) Application Details - K103549
Device Classification Name
Infant Heel Warmer (Chemical Heat Pack)
More FDA Info for this Device
510(K) Number
K103549
Device Name
Infant Heel Warmer (Chemical Heat Pack)
Applicant
DENOVO PRODUCTS LLC
17051 Alico Commerce Court
Unit 3
Fort Myers, FL 33967 US
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Contact
DALE WALTERS
Other 510(k) Applications for this Contact
Regulation Number
890.5710
More FDA Info for this Regulation Number
Classification Product Code
MPO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/03/2010
Decision Date
04/08/2011
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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