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 Other 510(k) Applications for this Company
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 Other 510(k) Applications for this Device   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