BRISTOL BALLON INTRODUCER, MANDRIL SET— 510(k) K813332

Name: FDA 510(k) clearance K813332
Creator: U.S. Food and Drug Administration
Published: 1981-12-14

Substantially Equivalent

Inmed Corp.

FDA 510(k) clearance K813332 for BRISTOL BALLON INTRODUCER, MANDRIL SET, Substantially Equivalent on 1981-12-14. Applicant: Inmed Corp.. Device class: 2.

Clearance details

Applicant: Inmed Corp.
Product code: Code NWU
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1981-11-24
Decision date: 1981-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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