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FDA 510(k), K131177, SINUFLUSH LAVAGE SYSTEM
FDA 510(k), K131177, SINUFLUSH LAVAGE SYSTEM
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510(K) Number: K131177
Device Name: SINUFLUSH LAVAGE SYSTEM
Manufacturer: HEDGEPATH, LLC
Device Classification Name: irrigator, sinus
Regulation Number: 874.4420
Classification Product Code: KAR
Date Received: 04/25/2013
Decision Date: 09/20/2013
Regulation Medical Specialty: Ear Nose & Throat
Device Name: SINUFLUSH LAVAGE SYSTEM
Manufacturer: HEDGEPATH, LLC
Device Classification Name: irrigator, sinus
Regulation Number: 874.4420
Classification Product Code: KAR
Date Received: 04/25/2013
Decision Date: 09/20/2013
Regulation Medical Specialty: Ear Nose & Throat
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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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