HYDROPHILIC GUIDEWIRE

Device Classification Name

wire, guide, catheter

510(k) Number K033758
Device Name HYDROPHILIC GUIDEWIRE
Applicant
LAKE REGION MFG., INC.
340 lake hazeltine dr.
chaska, 
MN 
55318

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

Correspodent Contact karen mortensen
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 12/02/2003
Decision Date 12/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No