FDA 510(k) Application Details - K971281

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K971281
Device Name	Wire, Guide, Catheter
Applicant	MEDCOMP 1499 DELP DR. HARLEYSVILLE, PA 19438 US Other 510(k) Applications for this Company
Contact	JEANNE M CUSH Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1997
Decision Date	10/09/1997
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