MANDREL GUIDEWIRES OR M-WIRE


Device Classification Name

endoscopic guidewire, gastroenterology-urology

510(k) Number K080508
Device Name MANDREL GUIDEWIRES OR M-WIRE
Applicant
LAKE REGION MEDICAL
340 lake hazeltine drive
chaska, 
MN 
55318

Applicant Contact karen mortensen
Correspondent
LAKE REGION MEDICAL
340 lake hazeltine drive
chaska, 
MN 
55318

Correspodent Contact karen mortensen
Regulation Number 876.1500
Classification Product Code
OCY  
Subsequent Product Codes
EZB   FAD   FGE   GCA   KNY  
LJE  
Date Received 02/25/2008
Decision Date 03/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No