LRM


Device Classification Name

wire, guide, catheter

510(k) Number K960718
Device Name LRM
Applicant
LAKE REGION MFG., INC.
340 lake hazeltine dr.
chaska, 
MN 
55318

Applicant Contact kim e aves
Correspondent
LAKE REGION MFG., INC.
340 lake hazeltine dr.
chaska, 
MN 
55318

Correspodent Contact kim e aves
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 02/21/1996
Decision Date 05/21/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No