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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 K180758
Device Name Osteocera Resorbable Bone Substitute
Applicant
Wiltrom Corporation Limited
1f., # 26, Sec. 2, Shengyi Rd.
Zhubei City,  TW 30261
Applicant Contact Yi-Chun Su
Correspondent
Wiltrom Corporation Limited
1f., # 26, Sec. 2, Shengyi Rd.
Zhubei City,  TW 30261
Correspondent Contact Yi-Chun Su
Regulation Number888.3045
Classification Product Code
MQV  
Date Received03/22/2018
Decision Date 10/24/2018
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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