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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Cement Restrictor
510(k) Number K021788
Device Name NBD CEMENT RESTRICTOR DEVICE
Applicant
New Business Development, LLC
605 Industrial Ct.
Woodstock,  GA  30189
Applicant Contact TIM B LUSBY
Correspondent
New Business Development, LLC
605 Industrial Ct.
Woodstock,  GA  30189
Correspondent Contact TIM B LUSBY
Regulation Number878.3300
Classification Product Code
JDK  
Date Received05/31/2002
Decision Date 10/04/2002
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
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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