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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K062260
Device Name OSTEOBOOST-BMA
Applicant
Orthos Limited
3 The Stables Leigh Ct. Pill Rd.
Abbots Leigh
Bristol, North Somerset,  GB BS8 3RA
Applicant Contact ALAN RORKE
Correspondent
Orthos Limited
3 The Stables Leigh Ct. Pill Rd.
Abbots Leigh
Bristol, North Somerset,  GB BS8 3RA
Correspondent Contact ALAN RORKE
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/04/2006
Decision Date 10/26/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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