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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 K081312
Device Name ARAGON ONESHOT SYSTEM
Applicant
Aragon Surgical, Inc.
1810 Embarcadero Rd., Suite B
Palo Alto,  CA  94303
Applicant Contact ALAN CURTIS
Correspondent
Aragon Surgical, Inc.
1810 Embarcadero Rd., Suite B
Palo Alto,  CA  94303
Correspondent Contact ALAN CURTIS
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/09/2008
Decision Date 10/31/2008
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
Predetermined Change
Control Plan Authorized		 No
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