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510(k) K953451

UROPUMP TUBE & DAMPING CHAMGER by Life-Tech Intl., Inc. — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1995
Date Received
July 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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  • K940203 — TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS (March 30, 1994)
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  • K960503 — DANTEC DUET (September 16, 1996)