FDA 510(k) Application Details - K984371

Device Classification Name Dressing, Wound And Burn, Occlusive

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510(K) Number K984371
Device Name Dressing, Wound And Burn, Occlusive
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 000.0000

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Classification Product Code MGP
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Date Received 12/07/1998
Decision Date 03/03/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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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