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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
510(k) Number K191569
Device Name Implantcast ic-Bipolar Head System
Applicant
Implantcast, GmbH
Luneburger Schanze 26
Buxtehude,  DE 21614
Applicant Contact Juliiane Hoppner
Correspondent
Mcra, LLC
1050 K Street NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Codes
LZO   MEH  
Date Received06/13/2019
Decision Date 08/28/2019
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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