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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 K053441
Device Name BIOGEL LATEX POWDER FREE STERILE SURGEON'S GLOVE
Applicant
Regent Medical Americas, LLC
3585 Engineering Dr., Suite 250
Norcross,  GA  30092
Applicant Contact KATHLEEN HARRIS
Correspondent
Regent Medical Americas, LLC
3585 Engineering Dr., Suite 250
Norcross,  GA  30092
Correspondent Contact KATHLEEN HARRIS
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/09/2005
Decision Date 04/10/2006
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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