OSCAR, MODEL OE3000DB


Device Classification Name

instrument, surgical, sonic and accessory/attachment

510(k) Number K051053
Device Name OSCAR, MODEL OE3000DB
Applicant
ORTHOSONICS, LTD.
2305 gold mine rd.
brookeville, 
MD 
20833

Applicant Contact t. whit athey
Correspondent
ORTHOSONICS, LTD.
2305 gold mine rd.
brookeville, 
MD 
20833

Correspodent Contact t. whit athey
Regulation Number 888.4580
Classification Product Code
JDX  
Subsequent Product Code
LZV  
Date Received 04/25/2005
Decision Date 07/21/2005
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