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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name couch, radiation therapy, powered
510(k) Number K120916
Device Name QFIX RADIOTHERAPY CHAIR
Original Applicant
WFR/AQUAPLAST CORP.
440 church road
avondale,  PA  19311
Original Contact tim wade
Regulation Number892.5770
Classification Product Code
JAI  
Date Received03/27/2012
Decision Date 06/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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