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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Isotope, Sealed, Gold, Titanium, Platinum
510(k) Number K882449
Device Name CESIUM 137 SOURCE, MODEL CSM-40
Applicant
Cis-Us, Inc.
10 De Angelo Dr.
Bedford,  MA  01730
Applicant Contact RITA T MCCULLOUGH
Correspondent
Cis-Us, Inc.
10 De Angelo Dr.
Bedford,  MA  01730
Correspondent Contact RITA T MCCULLOUGH
Regulation Number892.5730
Classification Product Code
IWI  
Date Received06/14/1988
Decision Date 04/14/1989
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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