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510(k) K910308

X-RAY TUBE HOUSING ASSEMBLY POLARIX II GEN/XO 110 by Inmark Corp. — Product Code ITY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1991
Date Received
January 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assembly, Tube Housing, X-Ray, Diagnostic
Device Class
Class I
Regulation Number
892.1760
Review Panel
RA
Submission Type

Other clearances by Inmark Corp.

  • K910276 — X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51 (March 6, 1991)
  • K894742 — RELOADING OF X-RAY TUBE HOUSING ASSEM., VARIOUS (October 27, 1989)
  • K894413 — X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS (September 22, 1989)

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  • K920731 — X-RAY TUBE ASSEMBLY CIRCLEX1.2UG (May 29, 1992)
  • K920724 — HIGH SPEED ROTATION STARTER SA-50 (April 27, 1992)
  • K920723 — HIGH SPEED ROTATION STARTER SA-40 (April 27, 1992)