FDA 510(k) Application Details - K080598

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K080598
Device Name Abutment, Implant, Dental, Endosseous
Applicant INTRA-LOCK INTERNATIONAL
6560 WEST ROGERS CIRCLE
SUITE 24
BOCA RATON, FL 33487 US
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Contact JEFFREY SAKOFF
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 03/03/2008
Decision Date 05/21/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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