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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 K043015
Device Name 3L SURGICAL DRAPES
Applicant
3l Medical Products Co., Ltd.
1800 Century Park E. Suite 600
Los Angeles,  CA  90067
Applicant Contact GEORGE SU
Correspondent
3l Medical Products Co., Ltd.
1800 Century Park E. Suite 600
Los Angeles,  CA  90067
Correspondent Contact GEORGE SU
Regulation Number878.4370
Classification Product Code
KKX  
Date Received11/02/2004
Decision Date 08/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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