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510(k) K915766

MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS by J. L. Shepherd and Assoc. — Product Code MOT

K915766 is an FDA 510(k) premarket notification submitted by J. L. Shepherd and Assoc. for the device "MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS". The FDA issued a decision of Substantially Equivalent on July 12, 1995. The device falls under product code MOT (Irradiator, Blood To Prevent Graft Versus Host Disease), a Class U device. J. L. Shepherd and Assoc. has at least 1 other 510(k) clearance on record.

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.

  • K915767 — MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS (July 12, 1995)

Other clearances for product code MOT

  • K201177 — RadGil2 (August 17, 2020)
  • K181737 — Raycell MK1 (January 2, 2019)
  • K172087 — SANGRAY (October 27, 2017)
  • K161324 — Raycell Mk2 (August 12, 2016)
  • K082921 — RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 (February 17, 2009)
  • K051065 — RAYCELL X-RAY BLOOD IRRADIATOR (May 26, 2005)
  • K050963 — GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN (May 20, 2005)
  • K032684 — RAYCELL (September 26, 2003)
  • K974210 — SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000 (March 30, 1998)
  • K963497 — GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 (November 8, 1996)

FDA data resources