FDA 510(k) Application Details - K233789

Device Classification Name Apparatus, Exhaust, Surgical

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510(K) Number K233789
Device Name Apparatus, Exhaust, Surgical
Applicant Surnic Corporation
480 Apollo Street, Ste. D
Brea, CA 92821 US
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Contact Helen Xie
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Regulation Number 878.5070

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Classification Product Code FYD
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Date Received 11/28/2023
Decision Date 04/10/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233789


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