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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Beam-Shaping, Radiation Therapy
510(k) Number K901567
Device Name THE HUESTIS COMPU-PLOTTER
Applicant
Huestis Machine Corp.
68 Buttonwood St.
Bristol,  RI  02809
Applicant Contact TERRY CHWALK
Correspondent
Huestis Machine Corp.
68 Buttonwood St.
Bristol,  RI  02809
Correspondent Contact TERRY CHWALK
Regulation Number892.5710
Classification Product Code
IXI  
Date Received04/03/1990
Decision Date 05/31/1990
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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