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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K914761
Device Name KAY-MED SURGICAL DEAPE/DRAP ACCESSORIES
Applicant
Kayco Medical, Inc.
4147 W. Armitage Ave.
Chicago,  IL  60639
Applicant Contact HEUNG-SOO KIM
Correspondent
Kayco Medical, Inc.
4147 W. Armitage Ave.
Chicago,  IL  60639
Correspondent Contact HEUNG-SOO KIM
Regulation Number878.4370
Classification Product Code
KKX  
Date Received10/22/1991
Decision Date 04/06/1992
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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