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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 K050184
Device Name BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX 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 Received01/27/2005
Decision Date 03/16/2005
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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