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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K060556
Device Name BRIGIT SURGICAL DEVICE
Applicant
ZIMMER INC.
345 E. MAIN ST.
WARSAW,  IN  46580
Applicant Contact TONI KINGSLEY
Correspondent
ZIMMER INC.
345 E. MAIN ST.
WARSAW,  IN  46580
Correspondent Contact TONI KINGSLEY
Regulation Number882.4560
Classification Product Code
HAW  
Date Received03/02/2006
Decision Date 07/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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