FDA 510(k), K092156, CAD 12, COLONOSCOPY ASSIST DEVICE

510(K) Number: K092156
Device Name: CAD 12, COLONOSCOPY ASSIST DEVICE
Manufacturer: SOFTSCOPE MEDICAL TECHNOLOGIES, INC.
Device Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 07/16/2009
Decision Date: 10/14/2009
Regulation Medical Specialty: Gastroenterology/Urology

75 pages (253 of original 328 pages are fully redacted)