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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Microsurgical
510(k) Number K926048
Device Name CLARUS ENDOSCOPIC BALL PROBE
Applicant
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Applicant Contact GREGORY J MATHISON
Correspondent
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Correspondent Contact GREGORY J MATHISON
Regulation Number882.4525
Classification Product Code
GZX  
Date Received12/01/1992
Decision Date 04/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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