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FDA 510(k), K161039, NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
FDA 510(k), K161039, NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
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$149.00 USD
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$149.00 USD
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510(K) Number: K161039
Device Name: NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
Manufacturer: NeoMed, Inc.
Device Classification Name: enteral syringes with enteral specific connectors
Regulation Number: 876.5980
Classification Product Code: PNR
Date Received: 04/13/2016
Decision Date: 06/17/2016
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL)
Manufacturer: NeoMed, Inc.
Device Classification Name: enteral syringes with enteral specific connectors
Regulation Number: 876.5980
Classification Product Code: PNR
Date Received: 04/13/2016
Decision Date: 06/17/2016
Regulation Medical Specialty: Gastroenterology/Urology
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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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