Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns— 510(k) K160337

Name: FDA 510(k) clearance K160337
Creator: U.S. Food and Drug Administration
Published: 2017-07-07

Substantially Equivalent

Bam Corporation Limited

FDA 510(k) clearance K160337 for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns, Substantially Equivalent on 2017-07-07. Applicant: Bam Corporation Limited. Device class: 2.

Clearance details

Applicant: Bam Corporation Limited
Product code: Code QPC
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2016-02-08
Decision date: 2017-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.