FDA 510(k) Application Details - K002241

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K002241
Device Name Implant, Endosseous, Root-Form
Applicant QUANTUM BIOENGINEERING, LTD.
201 UNUVERSITY DR., SUITE 101
PLANTATION, FL 34134 US
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Contact FLOYD G LARSON
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 07/24/2000
Decision Date 09/20/2001
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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