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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K904005
Device Name HUESTIS FLEXI-BOARD
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 Number892.5900
Classification Product Code
JAD  
Date Received08/29/1990
Decision Date 11/29/1990
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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