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FDA 510(k) Application Details - K241916
Device Classification Name
Bandage, Liquid
More FDA Info for this Device
510(K) Number
K241916
Device Name
Bandage, Liquid
Applicant
OptMed, Inc.
745 Fifth Avenue
Suite 500
New York, NY 10151 US
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Contact
Nitasha Yajnik
Other 510(k) Applications for this Contact
Regulation Number
880.5090
More FDA Info for this Regulation Number
Classification Product Code
KMF
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More FDA Info for this Product Code
Date Received
07/01/2024
Decision Date
09/27/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K241916
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