FDA 510(k) Application Details - K051227

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K051227
Device Name	Sleeve, Limb, Compressible
Applicant	RENU MEDICAL, INC. 9800 EVERGREEN WAY EVERETT, WA 98204 US Other 510(k) Applications for this Company
Contact	GEORGE BIGGINS 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	05/12/2005
Decision Date	04/07/2006
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