FDA 510(k) Application Details - K770117

Device Classification Name Frame, Rubber Dam

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510(K) Number K770117
Device Name Frame, Rubber Dam
Applicant HYGIENIC DENTAL MFG., CO., THE

, US
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Regulation Number 872.6300

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Classification Product Code EJE
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Date Received 01/21/1977
Decision Date 01/28/1977
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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