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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 K241802
Device Name Device 300397 Putty
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Marco Steiner
Correspondent
Telos Partners, LLC
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Roshana Ahmed
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/21/2024
Decision Date 11/08/2024
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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