FDA 510K (K133393) GELPOINT PATH TRANSANAL ACCESS PLATFORM

Device Classification Name: Anoscope And Accessories
510(k) Number: K133393
Device Name: GELPOINT PATH TRANSANAL ACCESS PLATFORM
Applicant: APPLIED MEDICAL RESOURCES CORP.
Regulation Number:    876.1500
Classification Product Code: FER  
Date Received:    11/05/2013
Decision Date:    01/02/2014
Decision:    Substantially Equivalent (SESE)
Regulation Medical Specialty:    Gastroenterology/Urology

Total pages: 103
Fully redacted pages: 34
Content pages: 69