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510(k) K882449

CESIUM 137 SOURCE, MODEL CSM-40 by Cis-Us, Inc. — Product Code IWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1989
Date Received
June 14, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Isotope, Sealed, Gold, Titanium, Platinum
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

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  • K865027 — IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C (February 26, 1987)
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  • K860823 — ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT (August 19, 1986)
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