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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 K981809
Device Name CAROLINE GUIDE
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 Received05/21/1998
Decision Date 08/14/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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