ORTHOGUARD AB ANTIMICROBIAL SLEEVE


Device Classification Name

component, traction, invasive

510(k) Number K022676
Device Name ORTHOGUARD AB ANTIMICROBIAL SLEEVE
Original Applicant
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis, 
TN 
38116

Original Contact janet johnson green
Regulation Number 888.3040
Classification Product Code
JEC  
Subsequent Product Code
NJA  
Date Received 08/12/2002
Decision Date 09/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No