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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 K954439
Device Name ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE
Applicant
Oratec Interventions, Inc.
2629a Terminal Blvd.
Mountain View,  CA  94043
Applicant Contact JUGH SHARKEY
Correspondent
Oratec Interventions, Inc.
2629a Terminal Blvd.
Mountain View,  CA  94043
Correspondent Contact JUGH SHARKEY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/25/1995
Decision Date 12/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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