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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact T. WHIT ATHEY
Regulation Number888.4580
Classification Product Code
JDX  
Subsequent Product Code
LZV  
Date Received04/25/2005
Decision Date 07/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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