K140595 Trade / Radiological Health Enclosure Avantis Medical Systems Inc. / Avantis Medical Systems Inc. / Sponsor/Submitter Avantis Medical Systems Inc. / / /
Event
Product Issues / Product Recall / /
Facility
Facility Equipment / New Hampshire Avenue Document Control Center / New York Hospital Queens Medical Center / Court Sunnyvale / / /
IndustryTerm
accessory device / identical video processor / announcements concerning your device / predicate device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address http /
MedicalTreatment
catheter / /
Organization
Device Evaluation Center for Devices and Radiological Health Enclosure Avantis Medical Systems / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / New York Hospital Queens Medical Center / office of Device Evaluation / Division of Reproductive / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / CDRH's office of Surveillance / Reproductive / Gastro-Renal / and Urological Devices Office / /
Person
Silver Spring / Benjamin R. Fisher / Herbert P. Lerner / Louis Fries / / /
Position
Consultant / Regulatory Affairs / Director / Correspondent / Consultant Regulatory Affairs / Vice President Research and Development Phone / /
Product
Third Eye Panoramic Auxiliary Endoscopy System / K140595 Page 2 / phases of the colonoscopy procedure / /
ProvinceOrState
Maryland / California / /
Technology
radiation / two Third Eye Video Processors / fundamental scientific technology / two Video Processors / identical video processor / /
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue