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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 K951662
Device Name COMFIT/BEADED SURGEON'S GLOVE
Applicant
Wembley Rubber Products (M) Sdn Bhd
Lot 1, Jalan 3,
Kawasan Perusahaan Bandar Baru
Salak Tinggi, Sepang Selangor,  MY 43900
Applicant Contact ONG G CHEE
Correspondent
Wembley Rubber Products (M) Sdn Bhd
Lot 1, Jalan 3,
Kawasan Perusahaan Bandar Baru
Salak Tinggi, Sepang Selangor,  MY 43900
Correspondent Contact ONG G CHEE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/10/1995
Decision Date 05/17/1995
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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