FDA 510(k) Application Details - K020379

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K020379
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. HUDSON, MA 01749 US Other 510(k) Applications for this Company
Contact	MICHAEL CARROLL Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2002
Decision Date	05/06/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review