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Hygiene / Food and Drug Administration / Medical technology / Electron beam / Microbiology / Sterilization / Medical device / Endoscopy / Disinfectant / Medicine / Health / Technology


Page 2 Summary of FDA Requests and LIC Responses - Telecon April 20, 2011 ggC LANGFORD
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Document Date: 2011-06-27 00:47:31

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File Size: 315,29 KB

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City

Tucson / /

Company

K101 158 Trade / Langford IC Systems Inc. / Contact Person Langford IC Systems Inc. / /

Currency

pence / /

Event

FDA Phase / /

Facility

General Hospital / /

/

IndustryTerm

announcements concerning your device / liquid chemical sterilant / predicate device / residual chemicals / marketed predicate devices / manufacturing practice / stainless steel processing chamber / low foaming enzyme chemical detergent / /

MedicalCondition

MS / /

Organization

Division of Postmarket Surveillance / Division of Anesthesiology / M.B.A. Director Division of Anesthesiology / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / FDA / Infection Control and Dental Devices Office / General Hospital / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / Center for Devices / /

Person

Anthony Watson / Manzi Detergent / /

/

Position

AOAC Official / AOAC Bacillus subtilis Official / Sterilants;Trcohtnm tgopte rcohtnmnarpye AQAC Official / Terry Langford President and CEO / /

Product

High / SYSTCM1S / Submerged solution / K101158 / /

ProvinceOrState

Arizona / /

Technology

radiation / LIC INSTRUMENT PROCESSOR / 2011 i2 LIC INSTRUMENT PROCESSOR / INSTRUMENT PROCESSOR / -1 LIC INSTRUMENT PROCESSOR / 6.0 SUMMARY OF NONCLINICAL TESTS FOR THE LIC INSTRUMENT PROCESSOR / /

URL

www.fda.agov/AbOLutF / www.fda.pov/MedicalDevices/ResouircesforYou/Iiidtstry/default.htm / /

SocialTag