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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K981153
Device Name OSIRIS
Applicant
Huestis Medical
68 Buttonwood St.
P.O. Box 718
Bristol,  RI  02807
Applicant Contact TERRY CHWALK
Correspondent
Huestis Medical
68 Buttonwood St.
P.O. Box 718
Bristol,  RI  02807
Correspondent Contact TERRY CHWALK
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/30/1998
Decision Date 03/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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