CORDGUARD BLOOD COLLECTION DEVICE— 510(k) K912419

Name: FDA 510(k) clearance K912419
Creator: U.S. Food and Drug Administration
Published: 1992-10-05

Substantially Equivalent

O.B. Tech., Inc.

FDA 510(k) clearance K912419 for CORDGUARD BLOOD COLLECTION DEVICE, Substantially Equivalent on 1992-10-05. Applicant: O.B. Tech., Inc.. Device class: 2.

Clearance details

Applicant: O.B. Tech., Inc.
Product code: Code HFW
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1991-05-31
Decision date: 1992-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, US

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