FDA 510(k) Application Details - K051751

Device Classification Name Headgear, Extraoral, Orthodontic

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510(K) Number K051751
Device Name Headgear, Extraoral, Orthodontic
Applicant ORTHO TECHNOLOGY
17401 COMMERCE PARK BOULEVARD
TAMPA, FL 33647 US
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Contact STEVE KLAMIC
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Regulation Number 872.5500

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Classification Product Code DZB
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Date Received 06/29/2005
Decision Date 07/22/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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