FDA 510(k) Application Details - K955872

Device Classification Name Drape, Surgical

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510(K) Number K955872
Device Name Drape, Surgical
Applicant MEDAL INTL. SALES CO., LLC.
100 EAST 15TH ST.
SUITE 320
FT. WORTH, TX 76102 US
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Contact RICHARD A HAMER
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 12/28/1995
Decision Date 03/12/1996
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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