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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 K080827
Device Name HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810
Applicant
Handan Hengyong Protective & Clean Products Co., L
1-1-1201, 455 Gongnong Rd.
Shijiazhuang, Hebei Province,  CN 050051
Applicant Contact MAGGIE ZHONG
Correspondent
Handan Hengyong Protective & Clean Products Co., L
1-1-1201, 455 Gongnong Rd.
Shijiazhuang, Hebei Province,  CN 050051
Correspondent Contact MAGGIE ZHONG
Regulation Number878.4040
Classification Product Code
MSH  
Date Received03/25/2008
Decision Date 04/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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