ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080482
Device Name ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01
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  
Subsequent Product Code
GXI  
Date Received 02/22/2008
Decision Date 03/20/2008
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