FDA 510(k) Application Details - K203623

Device Classification Name

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510(K) Number K203623
Device Name StentBoost Mobile
Applicant Philips India Limited
Plot No. B-79, MIDC, Phase-II, Chakan, Taluka-
Khed, Village - Savardari
Pune 410501 IN
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Contact Shruti Sancheti
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Regulation Number

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Classification Product Code OWB
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Date Received 12/11/2020
Decision Date 04/05/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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