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FDA 510(k) Application Details - K223669
Device Classification Name
Sealant, Microbial
More FDA Info for this Device
510(K) Number
K223669
Device Name
Sealant, Microbial
Applicant
Adhezion Biomedical, LLC.
506 Pine Mountain Rd.
Hudson, NC 28638 US
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Contact
Richard Jones
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Regulation Number
878.4370
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Classification Product Code
NZP
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More FDA Info for this Product Code
Date Received
12/07/2022
Decision Date
06/12/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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