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FDA 510(k) Application Details - K221218
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K221218
Device Name
Dressing, Wound, Drug
Applicant
Argentum Medical, Inc.
2571 Kaneville Ct
Geneva, IL 60134 US
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Contact
Kathy Herzog
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
04/27/2022
Decision Date
10/26/2022
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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