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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 K991677
Device Name REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
Applicant
London International Group, Inc.
P.O. Box 8308
2926 Columbia Hwy.
Dothan,  AL  36304
Applicant Contact BRADLEY L PUGH
Correspondent
London International Group, Inc.
P.O. Box 8308
2926 Columbia Hwy.
Dothan,  AL  36304
Correspondent Contact BRADLEY L PUGH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/17/1999
Decision Date 04/12/2000
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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