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FDA 510(k), K202071, SURGIPHOR Wound Irrigation System
FDA 510(k), K202071, SURGIPHOR Wound Irrigation System
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510(K) Number: K202071
Device Name: SURGIPHOR Wound Irrigation System
Manufacturer: Orthophor, LLC
Device Classification Name: Lavage, Jet
Regulation Number: 880.5475
Classification Product Code: FQH
Date Received: 07/27/2020
Decision Date: 10/23/2020
Regulation Medical Specialty: General Hospital
Device Name: SURGIPHOR Wound Irrigation System
Manufacturer: Orthophor, LLC
Device Classification Name: Lavage, Jet
Regulation Number: 880.5475
Classification Product Code: FQH
Date Received: 07/27/2020
Decision Date: 10/23/2020
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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