FDA 510(k) Application Details - K233902

Device Classification Name Unit, Phacofragmentation

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510(K) Number K233902
Device Name Unit, Phacofragmentation
Applicant Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134 US
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Contact De Rama Rita
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Regulation Number 886.4670

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Classification Product Code HQC
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Date Received 12/11/2023
Decision Date 01/10/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233902


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