N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028— 510(k) K072067

Name: FDA 510(k) clearance K072067
Creator: U.S. Food and Drug Administration
Published: 2008-01-08

Substantially Equivalent

Shuenn Bao Shing Corporation

FDA 510(k) clearance K072067 for N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028, Substantially Equivalent on 2008-01-08. Applicant: Shuenn Bao Shing Corporation. Device class: 2.

Clearance details

Applicant: Shuenn Bao Shing Corporation
Product code: Code MSH
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 2007-07-27
Decision date: 2008-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

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