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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 K880047
Device Name HUESTIS COMPU-FORMER
Applicant
Huestis Machine Corp.
68 Buttonwood St.
Bristol,  RI  02809
Applicant Contact DONALD WILSON
Correspondent
Huestis Machine Corp.
68 Buttonwood St.
Bristol,  RI  02809
Correspondent Contact DONALD WILSON
Regulation Number892.5710
Classification Product Code
IXI  
Date Received01/06/1988
Decision Date 04/11/1988
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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