FDA 510(k) Application Details - K991755

Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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510(K) Number K991755
Device Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact LARA N SIMMONS
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Regulation Number 000.0000

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Classification Product Code MGQ
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Date Received 05/24/1999
Decision Date 04/17/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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