VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073— 510(k) K002912

Name: FDA 510(k) clearance K002912
Creator: U.S. Food and Drug Administration
Published: 2001-02-21

Substantially Equivalent

Sterinc

FDA 510(k) clearance K002912 for VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073, Substantially Equivalent on 2001-02-21. Applicant: Sterinc. Device class: 2.

Clearance details

Applicant: Sterinc
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2000-09-18
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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