FDA 510(k) Application Details - K061897

Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental

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510(K) Number K061897
Device Name Handpiece, Contra- And Right-Angle Attachment, Dental
Applicant ORTHOSOURCE, INC.
13343 SHERMAN WAY
NORTH HOLLYWOOD, CA 91605 US
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Contact LLOYD TAYLOR
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Regulation Number 872.4200

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Classification Product Code EGS
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Date Received 07/03/2006
Decision Date 02/14/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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