BH Medical Dental Barrier Sleeves and Barrier Film— 510(k) K190484

Name: FDA 510(k) clearance K190484
Creator: U.S. Food and Drug Administration
Published: 2019-09-10

Substantially Equivalent

Bh Medical Products Co., Ltd.

FDA 510(k) clearance K190484 for BH Medical Dental Barrier Sleeves and Barrier Film, Substantially Equivalent on 2019-09-10. Applicant: Bh Medical Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bh Medical Products Co., Ltd.
Product code: Code PEM
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2019-02-27
Decision date: 2019-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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