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510(k) K955019

UROTRACT I by Dornier Medtech America, Inc. — Product Code KQS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1995
Date Received
November 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Cystometric, Non-Electric And Accessories
Device Class
Class I
Regulation Number
876.4890
Review Panel
GU
Submission Type

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Other clearances for product code KQS

  • K872022 — UROVIEW (July 16, 1987)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)
  • K860040 — HYDRAJUST III UROLOGICAL TABLE (February 10, 1986)
  • K852127 — AMSCO URO-ENDO MOBILE TABLE (August 8, 1985)
  • K801723 — UR 150-UR 150T (August 13, 1980)
  • K791699 — HYDRADJUST II UROLOGICAL TABLE (October 22, 1979)
  • K760522 — TABLE, UROSURGICAL (December 16, 1976)