FDA 510(k) Application Details - K101890

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K101890
Device Name Abutment, Implant, Dental, Endosseous
Applicant MEGAGEN CO., LTD.
325 N. PUENTE STREET
UNIT B
BREA, CA 92821 US
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Contact JOYCE BANG
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 07/07/2010
Decision Date 02/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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