FDA 510(k) Application Details - K093658

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K093658
Device Name	Sleeve, Limb, Compressible
Applicant	RENU MEDICAL, INC. 9800 EVERGREEN WAY EVERETT, WA 98204 US Other 510(k) Applications for this Company
Contact	L. BRUCE PIERSON 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	11/25/2009
Decision Date	01/14/2010
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	N
Expedited Review