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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 K910648
Device Name THERAPY CHAIR SYSTEM
Applicant
Radiation Technology, Inc.
16 Pedley St., Wavell Heights
Brisbane, Queensland,  AU QLD 4012
Applicant Contact M. A ROSE
Correspondent
Radiation Technology, Inc.
16 Pedley St., Wavell Heights
Brisbane, Queensland,  AU QLD 4012
Correspondent Contact M. A ROSE
Regulation Number892.5770
Classification Product Code
JAI  
Date Received02/14/1991
Decision Date 07/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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