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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K151607
Device Name Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
Applicant
Lucenxia Prescience AG
Rathautrasse 7
Baar,  CH 6341
Applicant Contact Robert Hill
Correspondent
Lucenxia Prescience AG
Rathautrasse 7
Baar,  CH 6341
Correspondent Contact Robert Hill
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/15/2015
Decision Date 11/16/2015
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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