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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, Internal
510(k) Number K895086
Device Name GAUZE SPONGE
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
Classification Product Code
EFQ  
Date Received08/08/1989
Decision Date 10/23/1989
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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