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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 K191513
Device Name Altapore Shape
Applicant
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake,  IL  60073
Applicant Contact Phillip Romei
Correspondent
Baxter Healthcare Corporation
32650 N. Wilson Road
Round Lake,  IL  60073
Correspondent Contact Phillip Romei
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/07/2019
Decision Date 10/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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