ARAGON ONESHOT SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K081312
Device Name ARAGON ONESHOT SYSTEM
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

Correspodent Contact alan curtis
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 05/09/2008
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