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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K060397
Device Name RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED
Applicant
Pajunk GmbH Medizintechnologie
Karl-Hall-Strasse 1
Geisingen,  DE 78187
Applicant Contact CHRISTIAN QUASS
Correspondent
Pajunk GmbH Medizintechnologie
Karl-Hall-Strasse 1
Geisingen,  DE 78187
Correspondent Contact CHRISTIAN QUASS
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received02/15/2006
Decision Date 08/31/2006
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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