FDA 510(k) Application Details - K233150

Device Classification Name Nail, Fixation, Bone

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510(K) Number K233150
Device Name Nail, Fixation, Bone
Applicant Narang Medical LTD.
Narang Tower, 46, Community Center, Naraina, Phase -1
Delhi 110028 IN
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Contact Vivek Narang
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Regulation Number 888.3030

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Classification Product Code JDS
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Date Received 09/27/2023
Decision Date 02/20/2024
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 K233150


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