FDA 510(k) Application Details - K023631

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K023631
Device Name Abutment, Implant, Dental, Endosseous
Applicant ASTRA TECH, INC.
96 WEST MAIN ST.
P.O. BOX 809
NORTHBOROUGH, MA 01532 US
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Contact BRUCE R MANNING
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 10/29/2002
Decision Date 11/07/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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