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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 K020308
Device Name REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE
Applicant
Ssl America'S, Inc.
3585 Engineering Dr.,Suite 200
P.O. Box 926090
Norcross,  GA  30092 -9214
Applicant Contact JOYCE NING
Correspondent
Ssl America'S, Inc.
3585 Engineering Dr.,Suite 200
P.O. Box 926090
Norcross,  GA  30092 -9214
Correspondent Contact JOYCE NING
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/29/2002
Decision Date 04/03/2002
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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