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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Cement Removal Extraction
510(k) Number K021502
Device Name OSCAR, MODEL OE3000
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
Correspondent Contact T. WHIT ATHEY
Regulation Number888.4580
Classification Product Code
LZV  
Date Received05/09/2002
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
Predetermined Change
Control Plan Authorized		 No
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