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510(k) K843224

UROPUMP MODEL 1711 by Life-Tech Intl., Inc. — Product Code FFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1984
Date Received
August 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

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Other clearances for product code FFG

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  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM (November 20, 1984)
  • K833043 — UROMETER (February 4, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)
  • K813082 — UREOFIX 500 URINE MEASURING SYSTEM (December 31, 1981)