FDA 510(k) Application Details - K233355

Device Classification Name Suture, Nonabsorbable, Synthetic, Polypropylene

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510(K) Number K233355
Device Name Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant Cypris Medical
4541 N. Ravenswood Ave #202
Chicago, IL 60640 US
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Contact Dan Holton
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Regulation Number 878.5010

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Classification Product Code GAW
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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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