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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 K093075
Device Name ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT
Applicant
ARAGON SURGICAL INC.
1810 EMBARCADERO ROAD, SUITE B
PALO ALTO,  CA  94303
Applicant Contact ALAN CURTIS
Correspondent
ARAGON SURGICAL INC.
1810 EMBARCADERO ROAD, SUITE B
PALO ALTO,  CA  94303
Correspondent Contact ALAN CURTIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/30/2009
Decision Date 01/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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