FDA 510(k) Application Details - K955333

Device Classification Name Bracket, Plastic, Orthodontic

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510(K) Number K955333
Device Name Bracket, Plastic, Orthodontic
Applicant ORMCO CORP.
1332 SOUTH LONE HILL AVE.
GLENDORA, CA 91740 US
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Contact LARRY WILLS
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Regulation Number 872.5470

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Classification Product Code DYW
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Date Received 11/21/1995
Decision Date 01/04/1996
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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