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.510(k) SUMMAR Submitter: Nakanishi, Inc.W MAR[removed]
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Document Date: 2013-04-11 12:52:13

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File Size: 106,51 KB

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City

Tokyo / RICHARDSON TX / /

Company

Diane Rutherford Regulatory Engineer Ken Block Consulting / Nakanishi Incorporated C / K 113717 Trade / COwN / t4KANISHI INC. / Nakanishi Inc. / /

Country

Japan / /

Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

/

IndustryTerm

health care products / dental applications / marketed predicate devices / manufacturing practice / electrical equipment / announcements concerning your device / Software validation documentation / predicate device / software validation / /

Organization

FDA / Food and Drug Administration / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / office of Device Evaluation / /

Person

Rutherford / Toshihiko Shinozaki / /

/

Position

Runner / General / Assistant Manager / R&D Dept. Pharmaceutical Affairs / Medical Electrical Equipment General / /

Product

Federal Food / /

ProvinceOrState

Maryland / /

SocialTag