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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K891835
Device Name BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)
Applicant
Associated Ent., Inc.
P.O. Box 1925
Danville,  CA  94526
Applicant Contact C. W CHAN,PHD
Correspondent
Associated Ent., Inc.
P.O. Box 1925
Danville,  CA  94526
Correspondent Contact C. W CHAN,PHD
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/27/1989
Decision Date 06/22/1989
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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