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510(k) K990041

UROSTYM BIOFEEDBACK AND STIMULATION PROBES by Laborie Medical Tech Corp. — Product Code KPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1999
Date Received
January 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type

Other clearances by Laborie Medical Tech Corp.

  • K993721 — UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES (November 29, 1999)
  • K991479 — VISER PENILE TUMESCENCE MONITOR (July 7, 1999)
  • K963064 — ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM (June 5, 1997)
  • K950016 — CART, MODE NUMBER UDS-CART (March 30, 1995)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)

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