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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze / Sponge,Nonresorbable For External Use
510(k) Number K912779
Device Name GAUZE SPONGE,STERILE 2'S
Applicant
Keilei Intl., Inc.
Hamilton Business Park 88
Franklin Rd.
Dover,  NJ  07901
Applicant Contact ALBERT SHEN
Correspondent
Keilei Intl., Inc.
Hamilton Business Park 88
Franklin Rd.
Dover,  NJ  07901
Correspondent Contact ALBERT SHEN
Regulation Number878.4014
Classification Product Code
NAB  
Date Received06/24/1991
Decision Date 09/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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