FDA 510(k) Application Details - K032948

Device Classification Name Bandage, Liquid

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510(K) Number K032948
Device Name Bandage, Liquid
Applicant MEDPAK, LLC
568 PARKSIDE COURT
ALLENTOWN, PA 18104 US
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Contact JOSEPH G SANT'ANGELO
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 09/22/2003
Decision Date 06/25/2004
Decision SESU - SE - WITH LIMITATIONS
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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