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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 K140195
Device Name SURGICAL DRAPE
Applicant
Griffith-Lucas, LLC
7th Floor, Jingui Business Bldg., #982 Congyun Rd.
Baiyun District
Guangzhou, Guangdong,  CN 510420
Applicant Contact MIKE GU
Correspondent
Griffith-Lucas, LLC
7th Floor, Jingui Business Bldg., #982 Congyun Rd.
Baiyun District
Guangzhou, Guangdong,  CN 510420
Correspondent Contact MIKE GU
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/27/2014
Decision Date 09/10/2014
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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