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510(k) K161395

SPEC Model M13 by Source Production and Equipment Co., Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2016
Date Received
May 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Source Production and Equipment Co., Inc.

  • K162573 — Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Sourc (November 4, 2016)
  • K161396 — SPEC Model M23 (August 17, 2016)
  • K150895 — SPEC Model M16 (June 19, 2015)
  • K132969 — SPEC MODEL M15 (January 2, 2014)
  • K090366 — SPEC MODEL M-31 (April 22, 2009)
  • K052947 — SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE (April 19, 2006)

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