CORE DISPOSABLE INSUFFLATION TUBING— 510(k) K901413

Name: FDA 510(k) clearance K901413
Creator: U.S. Food and Drug Administration
Published: 1990-09-24

Substantially Equivalent

Core Dynamics, Inc.

FDA 510(k) clearance K901413 for CORE DISPOSABLE INSUFFLATION TUBING, Substantially Equivalent on 1990-09-24. Applicant: Core Dynamics, Inc.. Device class: 2.

Clearance details

Applicant: Core Dynamics, Inc.
Product code: Code HES
Device class: Class 2
Regulation: 21 CFR 884.1300
Advisory panel: Obstetrics/Gynecology
Date received: 1990-03-26
Decision date: 1990-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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