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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Surgical
510(k) Number K123787
Device Name GREENCROSS SURGICAL MASK
Applicant
Jingzhou Haixin Green Cross Medical Products Co.,L
6 Vanderblet Rd.
Acton,  MA  01720
Applicant Contact XIANGYANG SONG
Correspondent
Jingzhou Haixin Green Cross Medical Products Co.,L
6 Vanderblet Rd.
Acton,  MA  01720
Correspondent Contact XIANGYANG SONG
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/10/2012
Decision Date 07/17/2013
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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