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FDA 510(k), K210536, Irrisept Antimicrobial Wound Lavage
FDA 510(k), K210536, Irrisept Antimicrobial Wound Lavage
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510(K) Number: K210536
Device Name: Irrisept Antimicrobial Wound Lavage
Manufacturer: Irrimax Corporation
Device Classification Name: Lavage, Jet
Regulation Number: 880.5475
Classification Product Code: FQH
Date Received: 02/24/2021
Decision Date: 05/28/2021
Regulation Medical Specialty: General Hospital
Device Name: Irrisept Antimicrobial Wound Lavage
Manufacturer: Irrimax Corporation
Device Classification Name: Lavage, Jet
Regulation Number: 880.5475
Classification Product Code: FQH
Date Received: 02/24/2021
Decision Date: 05/28/2021
Regulation Medical Specialty: General Hospital
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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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