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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 K881821
Device Name STERILE SURGICAL LATEX GLOVE
Applicant
NCA MED INTL./NOBLE HOUSE, INC.
2601 ELLIOTT AVE., SUITE 4181
SEATTLE,  WA  98121
Applicant Contact ABEL KHEMIS
Correspondent
NCA MED INTL./NOBLE HOUSE, INC.
2601 ELLIOTT AVE., SUITE 4181
SEATTLE,  WA  98121
Correspondent Contact ABEL KHEMIS
Regulation Number878.4460
Classification Product Code
KGO  
Date Received04/29/1988
Decision Date 06/01/1988
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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