DISPOSABLE CERVICAL BRUSH— 510(k) K141057

Name: FDA 510(k) clearance K141057
Creator: U.S. Food and Drug Administration
Published: 2015-05-14

Substantially Equivalent

Ningbo Hls Medical Products Co., Ltd.

FDA 510(k) clearance K141057 for DISPOSABLE CERVICAL BRUSH, Substantially Equivalent on 2015-05-14. Applicant: Ningbo Hls Medical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ningbo Hls Medical Products Co., Ltd.
Product code: Code HHT
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2014-04-24
Decision date: 2015-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, US

Download summary PDF View on FDA.gov ↗

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