ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP


Device Classification Name

staple, implantable

510(k) Number K080972
Device Name ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP
Applicant
ETHICON ENDO-SUGERY, LLC
4545 creek rd.
cincinnati, 
OH 
45242

Applicant Contact ruth a wood
Correspondent
ETHICON ENDO-SUGERY, LLC
4545 creek rd.
cincinnati, 
OH 
45242

Correspodent Contact ruth a wood
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 04/04/2008
Decision Date 07/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No