FDA 510(k) Application Details - K041047

Device Classification Name Mask, Surgical

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510(K) Number K041047
Device Name Mask, Surgical
Applicant MEDSPRING GROUP, INCORPORATED
533 WEST 2600 SOUTH, SUITE 105
BOUNTIFUL, UT 84010 US
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Contact BRUCE DAVIS
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Regulation Number 878.4040

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Classification Product Code FXX
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Date Received 04/22/2004
Decision Date 12/01/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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