FDA 510(k) Application Details - K954716

Device Classification Name	Infant Heel Warmer (Chemical Heat Pack)   More FDA Info for this Device
510(K) Number	K954716
Device Name	Infant Heel Warmer (Chemical Heat Pack)
Applicant	DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES 200 DEBUSK LN. POWELL, TN 37849 US Other 510(k) Applications for this Company
Contact	DEBRA F MANNING 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	10/13/1995
Decision Date	01/11/1996
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