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510(k) K823382

NEPHROSTOMY CATHETER by Umi, Inc. — Product Code LJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1983
Date Received
November 12, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

Other clearances by Umi, Inc.

  • K883527 — GRID/RADIOGRAPHIC (September 2, 1988)
  • K831412 — CRM-100 COLOR VIDEO CAMERA (June 3, 1983)
  • K830924 — CRM-114 COLOR VIDEO CAMERA (April 18, 1983)

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