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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, BADEN-WURTTEMBERG,  DE 78187
Applicant Contact CHRISTIAN QUASS
Correspondent
PAJUNK GMBH MEDIZINTECHNOLOGIE
KARL-HALL-STRASSE 1
GEISINGEN, BADEN-WURTTEMBERG,  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
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