U-CLIP UNI-FIRE, MODEL M65


Device Classification Name

clip, implantable

510(k) Number K081082
Device Name U-CLIP UNI-FIRE, MODEL M65
Applicant
MEDTRONIC INC.
3051 s. newcombe way
lakewood, 
CO 
80227

Applicant Contact david d cox
Correspondent
MEDTRONIC INC.
3051 s. newcombe way
lakewood, 
CO 
80227

Correspodent Contact david d cox
Regulation Number 878.4300
Classification Product Code
FZP  
Date Received 04/16/2008
Decision Date 05/07/2008
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