FDA 510(k) Application Details - K951239

Device Classification Name Bracket, Plastic, Orthodontic

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510(K) Number K951239
Device Name Bracket, Plastic, Orthodontic
Applicant ORMCO CORP.
1332 SOUTH LONE HILL AVE.
GLENDORA, CA US
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Contact JEFFREY A ANDERSON
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Regulation Number 872.5470

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Classification Product Code DYW
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Date Received 03/20/1995
Decision Date 07/19/1995
Decision SE - Substantially Equivalent
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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