FDA 510(k) Application Details - K955382

Device Classification Name Mask, Surgical

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510(K) Number K955382
Device Name Mask, Surgical
Applicant 3M COMPANY
BUILDINGS 251-3 AND 270
ST. PAUL, MN 55144-1000 US
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Contact DOROTHEA VON BUSCH
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Regulation Number 878.4040

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Classification Product Code FXX
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Date Received 11/24/1995
Decision Date 05/01/1996
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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