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FDA 510(k), K202222, Irrisept Wound Debridement and Cleansing System
FDA 510(k), K202222, Irrisept Wound Debridement and Cleansing System
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510(K) Number: K202222
Device Name: Irrisept Wound Debridement and Cleansing System
Manufacturer: Irrimax Corporation
Device Classification Name: Lavage, Jet
Regulation Number: 880.5475
Classification Product Code: FQH
Date Received: 08/06/2020
Decision Date: 12/14/2020
Regulation Medical Specialty: General Hospital
Device Name: Irrisept Wound Debridement and Cleansing System
Manufacturer: Irrimax Corporation
Device Classification Name: Lavage, Jet
Regulation Number: 880.5475
Classification Product Code: FQH
Date Received: 08/06/2020
Decision Date: 12/14/2020
Regulation Medical Specialty: General Hospital
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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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