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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K091439
Device Name HEAD FIXATION ARC AND TABLE BASE
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 Number882.4460
Classification Product Code
HBL  
Date Received05/14/2009
Decision Date 08/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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