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510(k) K853119

URODYN 1000 by Dantec Electronics, Inc. — Product Code FFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1985
Date Received
July 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Retractor, Self-Retaining
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

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  • K884915 — DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER (October 4, 1989)
  • K881915 — DANTEC MAGNETIC STIMULATOR (October 17, 1988)
  • K874759 — 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE (April 14, 1988)
  • K874758 — DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE (April 14, 1988)
  • K874735 — DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE (January 22, 1988)
  • K870567 — EVOPORT 300 (October 6, 1987)
  • K872106 — DANTEC COUNTERPOINT (September 10, 1987)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)

Other clearances for product code FFO

  • K993544 — SPACE-OR RETRACTOR (December 22, 1999)
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  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)
  • K852083 — THE KENDALL URINARY OUTPUT MONITOR (September 20, 1985)