FDA 510(k) Application Details - K971892

Device Classification Name	Sleeve, Limb, Compressible   More FDA Info for this Device
510(K) Number	K971892
Device Name	Sleeve, Limb, Compressible
Applicant	BIOMEDICAL HORIZONS, INC. 1331 HORTON RD. P.O. BOX 889 JACKSON, MI 49203 US Other 510(k) Applications for this Company
Contact	WILLIAM J DONAHUE 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	05/22/1997
Decision Date	08/05/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review