FDA 510(k) Application Details - K994130

Device Classification Name Anoscope And Accessories

  More FDA Info for this Device
510(K) Number K994130
Device Name Anoscope And Accessories
Applicant SIGHTLINE TECHNOLOGIES LTD.
P.O. BOX 454
GINOT, SHOMRON 44853 IL
Other 510(k) Applications for this Company
Contact AHAVA STEIN
Other 510(k) Applications for this Contact
Regulation Number 876.1500

  More FDA Info for this Regulation Number
Classification Product Code FER
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/07/1999
Decision Date 06/30/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact