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510(k) K901997

X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS by Comet Ltd. C/O Radiology Resources, Inc. — Product Code IZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1990
Date Received
May 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mammographic
Device Class
Class II
Regulation Number
892.1710
Review Panel
RA
Submission Type

Other clearances by Comet Ltd. C/O Radiology Resources, Inc.

  • K912338 — TUBE HOUSING ASSEMBLIES (August 7, 1991)
  • K911695 — VARIOUS X-RAY TUBES (June 19, 1991)
  • K910842 — DI2000/HS-45-150 X-RAY TUBE INSERT (March 6, 1991)
  • K864749 — TELAMAT (February 10, 1987)

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