KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR— 510(k) K951140

Name: FDA 510(k) clearance K951140
Creator: U.S. Food and Drug Administration
Published: 1995-05-25

Substantially Equivalent

Balagan Medical, Inc.

FDA 510(k) clearance K951140 for KORDKLAMP UMBILICAL CORD CLAMP APPLICATOR, Substantially Equivalent on 1995-05-25. Applicant: Balagan Medical, Inc.. Device class: 2.

Clearance details

Applicant: Balagan Medical, Inc.
Product code: Code HFW
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1995-03-13
Decision date: 1995-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, 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.