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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
Applicant
Wfr/Aquaplast Corp.
440 Church Rd.
Avondale,  PA  19311
Applicant Contact TIM WADE
Correspondent
Wfr/Aquaplast Corp.
440 Church Rd.
Avondale,  PA  19311
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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