FDA 510(k) Application Details - K971320

Device Classification Name	Dilator, Esophageal   More FDA Info for this Device
510(K) Number	K971320
Device Name	Dilator, Esophageal
Applicant	BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. NATICK, MA 01760-1537 US Other 510(k) Applications for this Company
Contact	LISA M QUAGLIA Other 510(k) Applications for this Contact
Regulation Number	876.5365   More FDA Info for this Regulation Number
Classification Product Code	KNQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/1997
Decision Date	10/09/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review