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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone cement
510(k) Number K190766
Device Name PALACOS fast R+G
Applicant
Heraeus Medical GmbH
Philipp-Reis-Strasse 8/13
Wehrheim,  DE 61273
Applicant Contact Ute Greiner
Correspondent
Heraeus Medical GmbH
Philipp-Reis-Strasse 8/13
Wehrheim,  DE 61273
Correspondent Contact Ute Greiner
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received03/25/2019
Decision Date 05/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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