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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 K865097
Device Name AIMED GAUZE SPONGE
Applicant
Kor-Medical Industries, Ltd.
5423 N. Lincoln Ave.
Chicago,  IL  60625
Applicant Contact NORMAN Y LEE
Correspondent
Kor-Medical Industries, Ltd.
5423 N. Lincoln Ave.
Chicago,  IL  60625
Correspondent Contact NORMAN Y LEE
Classification Product Code
EFQ  
Date Received12/30/1986
Decision Date 01/20/1987
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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