FDA 510(k) Application Details - K963388

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K963388
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	MAXXIM MEDICAL 100 EAST 15TH ST. SUITE 320 FORT WORTH, TX 76102 US Other 510(k) Applications for this Company
Contact	RICHARD A HAMER Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/1996
Decision Date	03/11/1997
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