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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 K042305
Device Name OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
Applicant
Ossacur AG
975 Veronics Springs Rd.
Santa Barbara,  CA  93105
Applicant Contact KRISTI KISTNER
Correspondent
Ossacur AG
975 Veronics Springs Rd.
Santa Barbara,  CA  93105
Correspondent Contact KRISTI KISTNER
Regulation Number888.3045
Classification Product Code
MQV  
Date Received08/25/2004
Decision Date 10/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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