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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 K984389
Device Name TOP WHOLESOME FACE MASK
Applicant
TOP WHOLESOME ENTERPRISE CO., LTD.
A.P. NAKARINTR TOWER 18TH FL
333 MOO 9, SRINAKARINTR RD.
BANGNA,  TH 10260
Applicant Contact URAI CHAROENSUK
Correspondent
TOP WHOLESOME ENTERPRISE CO., LTD.
A.P. NAKARINTR TOWER 18TH FL
333 MOO 9, SRINAKARINTR RD.
BANGNA,  TH 10260
Correspondent Contact URAI CHAROENSUK
Regulation Number878.4040
Classification Product Code
FXX  
Date Received12/08/1998
Decision Date 04/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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