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FDA 510(k), K190305, Additive Cap
FDA 510(k), K190305, Additive Cap
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$149.00 USD
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510(K) Number: K190305
Device Name: Additive Cap
Manufacturer: Peter Lehel
Device Classification Name: Container, I.V.
Regulation Number: KPE
Classification Product Code: 02/12/2019
Date Received: 04/30/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Additive Cap
Manufacturer: Peter Lehel
Device Classification Name: Container, I.V.
Regulation Number: KPE
Classification Product Code: 02/12/2019
Date Received: 04/30/2019
Decision Date: Substantially Equivalent (SESE)
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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