UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018— 510(k) K961906

Name: FDA 510(k) clearance K961906
Creator: U.S. Food and Drug Administration
Published: 1996-11-19

Substantially Equivalent

Spectrum Medsystems Corp.

FDA 510(k) clearance K961906 for UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018, Substantially Equivalent on 1996-11-19. Applicant: Spectrum Medsystems Corp.. Device class: 1.

Clearance details

Applicant: Spectrum Medsystems Corp.
Product code: Code EYZ
Device class: Class 1
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1996-05-16
Decision date: 1996-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER1994-11-02
K933126 — COMFORTCARE SYSTEM1994-02-25

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