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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Paddie
510(k) Number K020736
Device Name TRAATEK COTTONOID PATTIES
Applicant
Traatek, Inc.
917 Duriston Rd.
Redwood City,  CA  94062
Applicant Contact TERRY JOHNSTON
Correspondent
Traatek, Inc.
917 Duriston Rd.
Redwood City,  CA  94062
Correspondent Contact TERRY JOHNSTON
Regulation Number882.4700
Classification Product Code
HBA  
Date Received03/06/2002
Decision Date 06/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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