SAFEED DISP. PLASTIC CATHETER— 510(k) K771212

Name: FDA 510(k) clearance K771212
Creator: U.S. Food and Drug Administration
Published: 1977-09-12

Substantially Equivalent

Terumo America, Inc.

FDA 510(k) clearance K771212 for SAFEED DISP. PLASTIC CATHETER, Substantially Equivalent on 1977-09-12. Applicant: Terumo America, Inc.. Device class: 2.

Clearance details

Applicant: Terumo America, Inc.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1977-07-05
Decision date: 1977-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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