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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 K910002
Device Name GENESYS AND THE ROI
Applicant
The Complete Systems Corp. Genesys
2301 Lucien Way
Suite 105
Maitland,  FL  32751
Applicant Contact BARRY RICHMAN
Correspondent
The Complete Systems Corp. Genesys
2301 Lucien Way
Suite 105
Maitland,  FL  32751
Correspondent Contact BARRY RICHMAN
Regulation Number892.5770
Classification Product Code
JAI  
Date Received01/02/1991
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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