FDA 510(k) Application Details - K033243

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K033243
Device Name Abutment, Implant, Dental, Endosseous
Applicant STRAUMANN USA
RESERVOIR PLACE,
1601 TRAPELO ROAD
WALTHAM, MA 02154 US
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Contact LINDA JALBERT
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 10/07/2003
Decision Date 10/20/2003
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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