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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 K973277
Device Name CAROLINE GUIDE/DELIA LOCALIZER
Applicant
SURGICAL SOLUTIONS, INC.
2550 BLUFFWOOD CIR.
IOWA CITY,  IA  52245
Applicant Contact MATTHEW A HOWARD III
Correspondent
SURGICAL SOLUTIONS, INC.
2550 BLUFFWOOD CIR.
IOWA CITY,  IA  52245
Correspondent Contact MATTHEW A HOWARD III
Regulation Number882.4560
Classification Product Code
HAW  
Date Received09/02/1997
Decision Date 11/17/1997
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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