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FDA 510(k), K800563, BLOM-SINGER DUCKBILL VOICE PROSTHESIS
FDA 510(k), K800563, BLOM-SINGER DUCKBILL VOICE PROSTHESIS
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510(K) Number: K800563
Device Name: BLOM-SINGER DUCKBILL VOICE PROSTHESIS
Manufacturer: BIVONA MEDICAL TECHNOLOGIES
Device Classification Name: prosthesis, laryngeal (taub)
Regulation Number: 874.3730
Classification Product Code: EWL
Date Received: 03/13/1980
Decision Date: 03/25/1980
Regulation Medical Specialty: Ear Nose & Throat
Device Name: BLOM-SINGER DUCKBILL VOICE PROSTHESIS
Manufacturer: BIVONA MEDICAL TECHNOLOGIES
Device Classification Name: prosthesis, laryngeal (taub)
Regulation Number: 874.3730
Classification Product Code: EWL
Date Received: 03/13/1980
Decision Date: 03/25/1980
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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