Elastomer Software / Holland Regulatory / M.D. / K141234 Trade / Owner ViOptix Inc. / ViOptix Inc. / Regulatory Specialists Inc. / /
Event
FDA Phase / /
Facility
Avenue Document Control Center / / /
IndustryTerm
device / announcements concerning your device / manufacturing practice requirements / marketed predicate devices / manufacturing practice / Internet address htt /
Organization
Device Evaluation Center for Devices and Radiological Health Enclosure K1 / Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / office of Device Evaluation / CDRI-Is office of Surveillance / Cardiovascular Devices Office / Avenue Document Control Center / /
K14[removed]5Attachment B[removed]k) Summary or 51 0(k) Statement