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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 K891717
Device Name PATIENT EXAMINATION GLOVES (VINYL)
Applicant
ULTI-MED INTL., INC.
1688 GLEN ELLYN RD.
GLENDALE HEIGHTS,  IL  60139
Applicant Contact DOMINICK VECCHIONE
Correspondent
ULTI-MED INTL., INC.
1688 GLEN ELLYN RD.
GLENDALE HEIGHTS,  IL  60139
Correspondent Contact DOMINICK VECCHIONE
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/21/1989
Decision Date 05/11/1989
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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