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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 K111458
Device Name GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
Applicant
Gri Medical & Electronic Technology Co., Ltd.
717 Lakeglen Dr.
Swanee,  GA  30024
Applicant Contact PENNY NORTHCUTT
Correspondent
Gri Medical & Electronic Technology Co., Ltd.
717 Lakeglen Dr.
Swanee,  GA  30024
Correspondent Contact PENNY NORTHCUTT
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/26/2011
Decision Date 12/01/2011
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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