FDA 510(k) Application Details - K092857

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K092857
Device Name Abutment, Implant, Dental, Endosseous
Applicant WHIP-MIX CORP.
361 FARMINGTON AVE.
P.O. BOX 17183
LOUISVILLE, KY 40209 US
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Contact STUART STEINBOCK
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 09/16/2009
Decision Date 03/04/2010
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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