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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K894010
Device Name SURGICAL GLOVES
Applicant
Green Cross Medical Supplies Corp.
301 N. Washington St.
P.O. Box 747
Falls Church,  VA  22046
Applicant Contact JOSEPH A KOLASCH
Correspondent
Green Cross Medical Supplies Corp.
301 N. Washington St.
P.O. Box 747
Falls Church,  VA  22046
Correspondent Contact JOSEPH A KOLASCH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received06/02/1989
Decision Date 10/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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