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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 K202475
Device Name PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G
Applicant
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Applicant Contact Yannick Nils Hermanns
Correspondent
Heraeus Medical GmbH
Philipp-Reis-Str. 8/13
Wehrheim,  DE 61273
Correspondent Contact Yannick Nils Hermanns
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Codes
JDZ   KIH   MBB  
Date Received08/28/2020
Decision Date 11/23/2020
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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