FDA 510(k) Application Details - K983554

Device Classification Name Bandage, Liquid

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510(K) Number K983554
Device Name Bandage, Liquid
Applicant MOLNLYCKE HEALTH CARE, INC.
500 BALDWIN TOWER
EDDYSTONE, PA 19022 US
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Contact MIGUEL A NEGRON
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 10/13/1998
Decision Date 11/10/1998
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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