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FDA 510(k), K121604, ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
FDA 510(k), K121604, ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
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510(K) Number: K121604
Device Name: ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
Manufacturer: JASON SWIFT
Device Classification Name: Anoscope And Accessories
Regulation Number: FER
Classification Product Code: 06/01/2012
Date Received: 07/27/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: ANOSPEC DISPOSABLE ANSOSCOPE WITH LIGHT
Manufacturer: JASON SWIFT
Device Classification Name: Anoscope And Accessories
Regulation Number: FER
Classification Product Code: 06/01/2012
Date Received: 07/27/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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