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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 K091343
Device Name MRI NEURO DRAPE
Applicant
Surgivision, Inc.
11874 S. Evelyn Cir.
Houston,  TX  77071
Applicant Contact J. HARVEY KNAUSS
Correspondent
Surgivision, Inc.
11874 S. Evelyn Cir.
Houston,  TX  77071
Correspondent Contact J. HARVEY KNAUSS
Regulation Number878.4370
Classification Product Code
KKX  
Date Received05/06/2009
Decision Date 09/22/2009
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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