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FDA 510(k), K033590, ERBE HELIX HYDRO-JET
FDA 510(k), K033590, ERBE HELIX HYDRO-JET
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510(K) Number: K033590
Device Name: ERBE HELIX HYDRO-JET
Manufacturer: ERBE USA, INC.
Device Classification Name: lavage, jet
Regulation Number: 880.5475
Classification Product Code: FQH
Date Received: 11/10/2003
Decision Date: 01/30/2004
Regulation Medical Specialty: General Hospital
Device Name: ERBE HELIX HYDRO-JET
Manufacturer: ERBE USA, INC.
Device Classification Name: lavage, jet
Regulation Number: 880.5475
Classification Product Code: FQH
Date Received: 11/10/2003
Decision Date: 01/30/2004
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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