FDA 510(k) Application Details - K033615

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K033615
Device Name	Sleeve, Limb, Compressible
Applicant	WHEATON FRANCISCAN SERVICES INC., SUPPLY CHAIN 1800 EAST 900 SOUTH SALT LAKE CITY, UT 84108 US Other 510(k) Applications for this Company
Contact	JACK SPEER 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	11/17/2003
Decision Date	02/13/2004
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	N
Expedited Review