OSCAR, MODEL OE3000


Device Classification Name

system, cement removal extraction

510(k) Number K021502
Device Name OSCAR, MODEL OE3000
Original Applicant
ORTHOSONICS, LTD.
2305 gold mine rd.
brookeville, 
MD 
20833

Original Contact t. whit athey
Regulation Number 888.4580
Classification Product Code
LZV  
Date Received 05/09/2002
Decision Date 06/06/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No