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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 K885089
Device Name SURGICAL GLOVES
Applicant
Wb Intl., Inc.
12491 SW 130th St.
Miami,  FL  33186
Applicant Contact DANIEL O BARRY
Correspondent
Wb Intl., Inc.
12491 SW 130th St.
Miami,  FL  33186
Correspondent Contact DANIEL O BARRY
Regulation Number878.4460
Classification Product Code
KGO  
Date Received12/12/1988
Decision Date 06/22/1989
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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