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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K913575
Device Name GAUZE PACKING, SURGICAL STERILE AND NON-STERILE
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
FRO  
Date Received08/12/1991
Decision Date 09/06/1991
Decision Substantially Equivalent (SESE)
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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