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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 K003699
Device Name MEDIVISION IGS SYSTEM
Applicant
MEDIVISION (U.S.A.), INC.
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Applicant Contact SANDRA WILLIAMSON
Correspondent
MEDIVISION (U.S.A.), INC.
1301 GOSHEN PKWY.
WEST CHESTER,  PA  19380
Correspondent Contact SANDRA WILLIAMSON
Regulation Number882.4560
Classification Product Code
HAW  
Date Received12/01/2000
Decision Date 02/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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