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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K052638
Device Name ABBOTT SPINE, INC. SPINNAKER SYSTEM
Applicant
Abbott Spine, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Applicant Contact LISA PETERSON
Correspondent
Abbott Spine, Inc.
5301 Riata Park Ct.
Bldg. F
Austin,  TX  78727
Correspondent Contact LISA PETERSON
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
KIH  
Date Received09/26/2005
Decision Date 11/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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