SELF CATH SET/SAFETY CATH— 510(k) K983010

Substantially Equivalent

Rusch Intl.

FDA 510(k) clearance K983010 for SELF CATH SET/SAFETY CATH, Substantially Equivalent on 1999-02-12. Applicant: Rusch Intl.. Device class: 2.

Clearance details

Applicant: Rusch Intl.
Product code: Code FCM
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1998-08-28
Decision date: 1999-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

Download summary PDF View on FDA.gov ↗

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K023666 — RUSCH GUIDED CHOLANGIOGRAPHY CATHETER2003-06-17
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K023964 — RUSCH MICROLARYNGEAL TUBE2002-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.