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FDA 510(k) Application Details - K180609
Device Classification Name
Abutment, Implant, Dental, Endosseous
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510(K) Number
K180609
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
Rodo Medical, Inc.
6399 San Ignacio Ave., Suite 100
San Jose, CA 95119 US
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Contact
Michael Parsons
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Regulation Number
872.3630
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Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
03/08/2018
Decision Date
05/23/2018
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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