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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 K011255
Device Name 3D LINE STEROTACTIC HARDWARE ACCESSORIES
Applicant
3D Line USA, Inc.
2807 Old Court Rd.
Baltimore,  MD  21208
Applicant Contact KAREN H RIGAMONTI
Correspondent
3D Line USA, Inc.
2807 Old Court Rd.
Baltimore,  MD  21208
Correspondent Contact KAREN H RIGAMONTI
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
IYE  
Date Received04/24/2001
Decision Date 12/20/2001
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
Recalls CDRH Recalls
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