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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 K010815
Device Name NTERO NOMAD SYSTEM
Applicant
Ntero Surgical, Inc.
1137d San Antonio Rd.
Palo Alto,  CA  94303
Applicant Contact D. BOMMI BOMMANNNAN
Correspondent
Ntero Surgical, Inc.
1137d San Antonio Rd.
Palo Alto,  CA  94303
Correspondent Contact D. BOMMI BOMMANNNAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/19/2001
Decision Date 06/15/2001
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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