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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K070968
Device Name CHOY COMPRESSION FRAME
Applicant
Choy Medical Technologies, Inc.
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Choy Medical Technologies, Inc.
555 Thirteenth St., NW
Columbia Sq.
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/05/2007
Decision Date 11/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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