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FDA 510(k) Application Details - K242828
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K242828
Device Name
Dressing, Wound, Collagen
Applicant
StimLabs, LLC
1225 Northmeadow Parkway
Suite 104
Roswell, GA 30011 US
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Contact
Melissa O'Connor
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
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More FDA Info for this Product Code
Date Received
09/19/2024
Decision Date
10/18/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K242828
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