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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 K892579
Device Name ANATOMICAL EXAMINATION GLOVES
Applicant
Ansell Pacific, Inc.
4750 S. Park Ave.
Tucson,  AZ  85714
Applicant Contact FRED DIETSCH
Correspondent
Ansell Pacific, Inc.
4750 S. Park Ave.
Tucson,  AZ  85714
Correspondent Contact FRED DIETSCH
Regulation Number880.6250
Classification Product Code
LYY  
Date Received04/10/1989
Decision Date 07/14/1989
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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