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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K061499
Device Name OSFERION
Applicant
Olympus America, Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus America, Inc.
3500 Corporate Pkwy.
P.O. Box 610
Center Valley,  PA  18034
Correspondent Contact LAURA STORMS-TYLER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/31/2006
Decision Date 01/26/2007
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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