FDA 510(k) Application Details - K863010

Device Classification Name Unit, Operative Dental

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510(K) Number K863010
Device Name Unit, Operative Dental
Applicant SDS DENTAL, INC.
4321 WISCONSIN AVE N.W
SUITE 200
WASHINGTON, DC US
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Contact CESAR CORAL
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Regulation Number 872.6640

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Classification Product Code EIA
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Date Received 08/08/1986
Decision Date 09/26/1986
Decision SE - Substantially Equivalent
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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