SUN MEDICAL LAMINARIA CERVICAL DILATOR— 510(k) K845006

Name: FDA 510(k) clearance K845006
Creator: U.S. Food and Drug Administration
Published: 1985-05-01

Substantially Equivalent

Sun Medical, Inc.

FDA 510(k) clearance K845006 for SUN MEDICAL LAMINARIA CERVICAL DILATOR, Substantially Equivalent on 1985-05-01. Applicant: Sun Medical, Inc.. Device class: 2.

Clearance details

Applicant: Sun Medical, Inc.
Product code: Code HDY
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Date received: 1984-12-26
Decision date: 1985-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, US

Download summary PDF View on FDA.gov ↗

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