OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K072937
Device Name OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
Applicant
OLSEN MEDICAL
3001 west kentucky st.
louisville, 
KY 
40211

Applicant Contact john p waters
Correspondent
OLSEN MEDICAL
3001 west kentucky st.
louisville, 
KY 
40211

Correspodent Contact john p waters
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 10/16/2007
Decision Date 12/28/2007
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