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510(k) K952029

RUSCH INTERNATIONAL URODYNAMIC CATHETERS by Rusch Intl. — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1995
Date Received
May 1, 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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  • K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED (July 23, 2002)
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  • K010798 — RUSCH CANTOR TUBE (February 26, 2002)
  • K010797 — RUSCH MILLER-ABBOTT TUBE (February 26, 2002)

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