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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K971514
Device Name REGENT BIOGEL DIAGNOSTIC PROCEDURE GLOVE
Applicant
London International Group, Inc.
2926 Columbia Highway
P.O. Box 8308
Dotham,  AL  36303
Applicant Contact NEIL ANDERSON
Correspondent
London International Group, Inc.
2926 Columbia Highway
P.O. Box 8308
Dotham,  AL  36303
Correspondent Contact NEIL ANDERSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/25/1997
Decision Date 10/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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