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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K010202
Device Name OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES
Applicant
Leslie W. Organ
1837 Kempton Rd.
Charleston,  SC  29412
Applicant Contact LESLIE W ORGAN
Correspondent
Leslie W. Organ
1837 Kempton Rd.
Charleston,  SC  29412
Correspondent Contact LESLIE W ORGAN
Regulation Number882.4400
Classification Product Code
GXD  
Subsequent Product Codes
GXI   GZL  
Date Received01/22/2001
Decision Date 10/31/2001
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
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