FDA 510(k) Application Details - K760779

Device Classification Name Cover, Shoe, Operating-Room

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510(K) Number K760779
Device Name Cover, Shoe, Operating-Room
Applicant SURGIKOS, INC.

, US
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Regulation Number 878.4040

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Classification Product Code FXP
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Date Received 10/05/1976
Decision Date 11/02/1976
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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