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FDA 510(k) Application Details - K240185
Device Classification Name
Carrier, Ligature
More FDA Info for this Device
510(K) Number
K240185
Device Name
Carrier, Ligature
Applicant
Cypris Medical
4541 N. Ravenswood Avenue, #202
Chicago, IL 60640 US
Other 510(k) Applications for this Company
Contact
Dan Holton
Other 510(k) Applications for this Contact
Regulation Number
878.4800
More FDA Info for this Regulation Number
Classification Product Code
GEJ
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More FDA Info for this Product Code
Date Received
01/23/2024
Decision Date
05/03/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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 K240185
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