ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080282
Device Name ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00;
Applicant
ARTHROCARE CORP.
680 vaqueros ave.
sunnyvale, 
CA 
94085 -3523

Applicant Contact valerie defiesta-ng
Correspondent
ARTHROCARE CORP.
680 vaqueros ave.
sunnyvale, 
CA 
94085 -3523

Correspodent Contact valerie defiesta-ng
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 02/04/2008
Decision Date 02/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No