FDA 510(k) Application Details - K240185

Device Classification Name Carrier, Ligature

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510(K) Number K240185
Device Name Carrier, Ligature
Applicant Cypris Medical
4541 N. Ravenswood Avenue, #202
Chicago, IL 60640 US
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Contact Dan Holton
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Regulation Number 878.4800

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Classification Product Code GEJ
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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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