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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 K090401
Device Name ORTHOSS
Applicant
Ed. Geistlich Soehne AG Fur Chemische Industrie
1300 I St., NW, 11th Floor
East
Washington,  DC  20005
Applicant Contact PETER S REICHERTZ
Correspondent
Ed. Geistlich Soehne AG Fur Chemische Industrie
1300 I St., NW, 11th Floor
East
Washington,  DC  20005
Correspondent Contact PETER S REICHERTZ
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/17/2009
Decision Date 01/08/2010
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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