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FDA 510(k), K171637, OpClear System
FDA 510(k), K171637, OpClear System
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510(K) Number: K171637
Device Name: OpClear System
Manufacturer: Cipher Surgical Ltd
Device Classification Name: endoscopic irrigation/suction system
Regulation Number: 876.1500
Classification Product Code: OCX
Date Received: 06/02/2017
Decision Date: 02/26/2018
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: OpClear System
Manufacturer: Cipher Surgical Ltd
Device Classification Name: endoscopic irrigation/suction system
Regulation Number: 876.1500
Classification Product Code: OCX
Date Received: 06/02/2017
Decision Date: 02/26/2018
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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