FDA 510(k) Application Details - K070184

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K070184
Device Name Implant, Endosseous, Root-Form
Applicant OSPOL AB
JORGEN KOCKSGATAN 9
MALMO SE-211 20 SE
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Contact LENNART CARLSSON
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 01/19/2007
Decision Date 03/24/2008
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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