FDA 510(k) Application Details - K760861

Device Classification Name Cap, Surgical

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510(K) Number K760861
Device Name Cap, Surgical
Applicant SURGIKOS, INC.

, US
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Regulation Number 878.4040

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Classification Product Code FYF
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Date Received 10/18/1976
Decision Date 11/03/1976
Decision SE - Substantially Equivalent
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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