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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 K031669
Device Name STERILE POWDER FREE SYNTHETIC SURGICAL GLOVE WITH POLYMER COATING
Applicant
P.T. Saptindo Surgica
Jalan Raya Serang Km 65,
Cikande
Serang-Banten,  ID 42186
Applicant Contact WIDAGDO GONDOWARDOYO
Correspondent
P.T. Saptindo Surgica
Jalan Raya Serang Km 65,
Cikande
Serang-Banten,  ID 42186
Correspondent Contact WIDAGDO GONDOWARDOYO
Regulation Number878.4460
Classification Product Code
KGO  
Date Received05/29/2003
Decision Date 09/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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