MANDREL GUIDEWIRES OR M-WIRES


Device Classification Name

wire, guide, catheter

510(k) Number K080144
Device Name MANDREL GUIDEWIRES OR M-WIRES
Applicant
LAKE REGION MFG., INC.
340 lake hazeltine dr.
chaska, 
MN 
55318

Applicant Contact deep pal
Correspondent
LAKE REGION MFG., INC.
340 lake hazeltine dr.
chaska, 
MN 
55318

Correspodent Contact deep pal
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 01/22/2008
Decision Date 02/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No