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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 K993854
Device Name ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
Applicant
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Applicant Contact SHIELA RAMERMAN
Correspondent
Oratec Interventions, Inc.
3700 Haven Ct.
Menlo Park,  CA  94025
Correspondent Contact SHIELA RAMERMAN
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HRX  
Date Received11/15/1999
Decision Date 12/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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