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510(k) K962472

RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER by Rusch Intl. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1996
Date Received
June 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

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  • K023918 — RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS (March 28, 2003)
  • K023964 — RUSCH MICROLARYNGEAL TUBE (December 23, 2002)
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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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  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)
  • K924086 — NICKI, MODEL NUMBER USD-NK-UP1 (October 20, 1992)