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FDA 510(k) Application Details - K984370
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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510(K) Number
K984370
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
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
MGQ
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More FDA Info for this Product Code
Date Received
12/07/1998
Decision Date
03/01/1999
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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