FDA 510(k) Application Details - K232593

Device Classification Name Prosthesis, Chin, Internal

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510(K) Number K232593
Device Name Prosthesis, Chin, Internal
Applicant Keosan Trading Co.
#805, #806, Human Teco B/D, 57, Achasan-ro 17-gil
Seongdong-gu
Seoul KR
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Contact Priscilla Chung
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Regulation Number 878.3550

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Classification Product Code FWP
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Date Received 08/25/2023
Decision Date 11/22/2023
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 K232593


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