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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 K994333
Device Name ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES
Applicant
ORATEC INTERVENTIONS, INC.
3700 HAVEN CT.
MENLO PARK,  CA  94025
Applicant Contact SHEILA RAMERMAN
Correspondent
ORATEC INTERVENTIONS, INC.
3700 HAVEN CT.
MENLO PARK,  CA  94025
Correspondent Contact SHEILA RAMERMAN
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HRX  
Date Received12/23/1999
Decision Date 01/18/2000
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
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