FDA 510(k) Application Details - K200166

Device Classification Name Clip, Implantable

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510(K) Number K200166
Device Name Clip, Implantable
Applicant M/s. Meril Endo Surgery Private Limited
Third Floor , E1-E3, Meril Park, Survey No. 135/2/B & 174/2,
Muktanand Marg
Chala, Vapi 396191 IN
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Contact Umesh Sharma
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Regulation Number 878.4300

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Classification Product Code FZP
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Date Received 01/22/2020
Decision Date 11/23/2020
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



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