FDA 510(k) Application Details - K233800

Device Classification Name Arthroscope

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510(K) Number K233800
Device Name Arthroscope
Applicant Vertos Medical Inc
95 Enterprise Unit 325
Aliso Viejo, CA 92656 US
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Contact Russ Alexander
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 11/29/2023
Decision Date 05/06/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233800


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