FDA 510(k) Application Details - K040511

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K040511
Device Name	Sleeve, Limb, Compressible
Applicant	TYCO HEALTHCARE/KENDALL 15 HAMPSHIRE STREET MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	BRIDGET GARDNER 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	02/27/2004
Decision Date	06/28/2004
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