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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 K842622
Device Name HEMO STATIC/ESU SCALPEL SYSTEM
Applicant
Oximetrix, Inc.
1212 Terra Bella Ave.
Mountain View,  CA  94043
Applicant Contact MICHAEL J BILLIG
Correspondent
Oximetrix, Inc.
1212 Terra Bella Ave.
Mountain View,  CA  94043
Correspondent Contact MICHAEL J BILLIG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/05/1984
Decision Date 10/23/1984
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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