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FDA 510(k), K151686, HumanPen Ergo II
FDA 510(k), K151686, HumanPen Ergo II
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$149.00 USD
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$149.00 USD
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510(K) Number: K151686
Device Name: HumanPen Ergo II
Manufacturer: ELI LILLY AND COMPANY, INC.
Device Classification Name: syringe, piston
Regulation Number: 880.5860
Classification Product Code: FMF
Date Received: 06/23/2015
Decision Date: 12/30/2015
Regulation Medical Specialty: General Hospital
Device Name: HumanPen Ergo II
Manufacturer: ELI LILLY AND COMPANY, INC.
Device Classification Name: syringe, piston
Regulation Number: 880.5860
Classification Product Code: FMF
Date Received: 06/23/2015
Decision Date: 12/30/2015
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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