FDA 510(k) Application Details - K241253

Device Classification Name Prosthesis, Nose, Internal

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510(K) Number K241253
Device Name Prosthesis, Nose, Internal
Applicant CMF Medicon Surgical Inc.
11200 St. Johns Industrial Pkwy N. Ste. 1
Jacksonville, FL 32246 US
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Contact Matthias Alber
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Regulation Number 878.3680

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Classification Product Code FZE
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Date Received 05/03/2024
Decision Date 12/12/2024
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 K241253


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