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510(k) K915767

MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS by J. L. Shepherd and Assoc. — Product Code MOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1995
Date Received
December 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class
Class U
Regulation Number
Review Panel
RA
Submission Type

Other clearances by J. L. Shepherd and Assoc.

  • K915766 — MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS (July 12, 1995)

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