VISU-LOCK 5MM CLIP APPLIER

Device Classification Name

clip, implantable

510(k) Number K033161
Device Name VISU-LOCK 5MM CLIP APPLIER
Applicant
GYRX, LLC
11222 st. johns industrial
parkway n.
jacksonville, 
FL 
32246

Applicant Contact cory edwards
Correspondent
GYRX, LLC
11222 st. johns industrial
parkway n.
jacksonville, 
FL 
32246

Correspodent Contact cory edwards
Regulation Number 878.4300
Classification Product Code
FZP  
Date Received 09/30/2003
Decision Date 12/18/2003
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