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FDA 510(k) Application Details - K233355
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
More FDA Info for this Device
510(K) Number
K233355
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
Cypris Medical
4541 N. Ravenswood Ave #202
Chicago, IL 60640 US
Other 510(k) Applications for this Company
Contact
Dan Holton
Other 510(k) Applications for this Contact
Regulation Number
878.5010
More FDA Info for this Regulation Number
Classification Product Code
GAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2023
Decision Date
01/12/2024
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 K233355
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