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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 K890311
Device Name KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE)
Applicant
Kosan Far East Ent. , Ltd.
Rm. 1606 Sino Centre
582-592 Nathan Rd. Kowloon
Hong Kong,  TW
Applicant Contact SHOZO SAITO
Correspondent
Kosan Far East Ent. , Ltd.
Rm. 1606 Sino Centre
582-592 Nathan Rd. Kowloon
Hong Kong,  TW
Correspondent Contact SHOZO SAITO
Regulation Number878.4460
Classification Product Code
KGO  
Date Received01/23/1989
Decision Date 03/03/1989
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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