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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
NO. 58, FU CHIUN STREET
HSIN CHU CITY,  TW 30067
Applicant Contact Ke-Min Jen
Correspondent
SHUENN BAO SHING CORPORATION
NO. 58, FU CHIUN STREET
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
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