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FDA 510(k) Application Details - K240277
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K240277
Device Name
Dressing, Wound, Collagen
Applicant
Reprise Biomedical, Inc.
17400 Medina Road
Suite 100
Plymouth, MN 55447 US
Other 510(k) Applications for this Company
Contact
Badali Erin
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/31/2024
Decision Date
03/01/2024
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 K240277
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