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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 K980942
Device Name REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE
Applicant
London International Group, Inc.
2926 Columbia Hwy.
P.O. Box 8308
Dotham,  AL  36303
Applicant Contact NEIL ANDERSON
Correspondent
London International Group, Inc.
2926 Columbia Hwy.
P.O. Box 8308
Dotham,  AL  36303
Correspondent Contact NEIL ANDERSON
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/12/1998
Decision Date 05/11/1998
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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