COALESCENT SURGICAL U-CLIP AND ACCESSORIES


Device Classification Name

clip, implantable

510(k) Number K024366
Device Name COALESCENT SURGICAL U-CLIP AND ACCESSORIES
Original Applicant
COALESCENT SURGICAL
559 east weddell dr.
sunnyvale, 
CA 
94089

Original Contact michael a daniel
Regulation Number 878.4300
Classification Product Code
FZP  
Subsequent Product Code
NJU  
Date Received 12/31/2002
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls