POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES


Device Classification Name

arthroscope

510(k) Number K080617
Device Name POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods pkwy.
vernon hills, 
IL 
60061

Applicant Contact niels schmidt
Correspondent
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 corporate woods pkwy.
vernon hills, 
IL 
60061

Correspodent Contact niels schmidt
Regulation Number 888.1100
Classification Product Code
HRX  
Subsequent Product Codes
ERL   GEY   HWE  
Date Received 03/04/2008
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No