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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 K900298
Device Name GAMASHIELD
Applicant
Formtex Medical Sdn. Bhd.
7, Leboh Hishamuddin Satu Kaw.
20 Kawasan Perusahaan Selat
Klang Pelabohan Klang,  MY 42000
Applicant Contact LOW
Correspondent
Formtex Medical Sdn. Bhd.
7, Leboh Hishamuddin Satu Kaw.
20 Kawasan Perusahaan Selat
Klang Pelabohan Klang,  MY 42000
Correspondent Contact LOW
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/23/1990
Decision Date 06/27/1990
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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