FDA 510(k) Application Details - K103247

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K103247
Device Name	Sleeve, Limb, Compressible
Applicant	THERMOTEK, INC. 1200 LAKESIDE PARKWAY #200 FLOWER MOUND, TX 75028 US Other 510(k) Applications for this Company
Contact	NIRAN BALACHANDRAN Other 510(k) Applications for this Contact
Regulation Number	870.5800   More FDA Info for this Regulation Number
Classification Product Code	JOW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2010
Decision Date	12/10/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review