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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 K894307
Device Name LAWANA PATIENT EXAMINATION GLOVES
Applicant
Viri Imports, Inc.
632 Mincey Woods Ct.
Stone Mountain,  GA  30087
Applicant Contact DAT M VU
Correspondent
Viri Imports, Inc.
632 Mincey Woods Ct.
Stone Mountain,  GA  30087
Correspondent Contact DAT M VU
Regulation Number880.6250
Classification Product Code
LYY  
Date Received06/23/1989
Decision Date 08/01/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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