FDA 510(k) Application Details - K022256

Device Classification Name Mask, Surgical

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510(K) Number K022256
Device Name Mask, Surgical
Applicant TUCKER & ASSOCIATES
198 AVE. DE LA D'EMERALD
SPARKS, NV 89434-9550 US
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Contact JANNA TUCKER
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Regulation Number 878.4040

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Classification Product Code FXX
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Date Received 07/12/2002
Decision Date 04/26/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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