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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K992805
Device Name ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
Applicant
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Applicant Contact JENNIFER BRENNAN
Correspondent
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Correspondent Contact JENNIFER BRENNAN
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HRX  
Date Received08/20/1999
Decision Date 02/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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