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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 K021869
Device Name OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP
Applicant
Diros Technology, Inc.
1837 Kempton Rd.
Charleston,  SC  29412
Applicant Contact LESLIE W ORGAN
Correspondent
Diros Technology, Inc.
1837 Kempton Rd.
Charleston,  SC  29412
Correspondent Contact LESLIE W ORGAN
Regulation Number882.4400
Classification Product Code
GXD  
Subsequent Product Codes
GXI   GZL  
Date Received06/06/2002
Decision Date 07/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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