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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respirator, Surgical
510(k) Number K072067
Device Name N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028
Applicant
Shuenn Bao Shing Corporation
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Applicant Contact Ke-Min Jen
Correspondent
Shuenn Bao Shing Corporation
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Correspondent Contact Ke-Min Jen
Regulation Number878.4040
Classification Product Code
MSH  
Date Received07/27/2007
Decision Date 01/08/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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