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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 K864064
Device Name LATEX SURGICAL GLOVES
Applicant
Futuremed Div. of Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Applicant Contact MORAD DAVOUDZADEH
Correspondent
Futuremed Div. of Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Correspondent Contact MORAD DAVOUDZADEH
Regulation Number878.4460
Classification Product Code
KGO  
Date Received10/20/1986
Decision Date 10/30/1986
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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