• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
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FDA 510(k) K192656, Optimized Positioning System (OPS) Insight, by Corin USA

FDA 510(k) K192656, Optimized Positioning System (OPS) Insight, by Corin USA

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510(K) Number: K192656
Device Name: Optimized Positioning System (OPS) Insight
Manufacturer: Corin USA
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 09/25/2019
Decision Date: 05/01/2020
Regulation Medical Specialty: Radiology

701 pages (2,420 of 3,121 original pages are fully redacted)
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