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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 K973158
Device Name ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE
Applicant
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Applicant Contact MICHAEL KWAN
Correspondent
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Correspondent Contact MICHAEL KWAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/22/1997
Decision Date 11/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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