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FDA 510(k), K121579, EK DELIVERY DEVICE
FDA 510(k), K121579, EK DELIVERY DEVICE
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510(K) Number: K121579
Device Name: EK DELIVERY DEVICE
Manufacturer: TDAK MEDICAL, INC
Device Classification Name: graft insertion instrument for endothelial keratoplasty
Regulation Number: 886.4300
Classification Product Code: OTZ
Date Received: 05/30/2012
Decision Date: 10/03/2012
Regulation Medical Specialty: Ophthalmic
Device Name: EK DELIVERY DEVICE
Manufacturer: TDAK MEDICAL, INC
Device Classification Name: graft insertion instrument for endothelial keratoplasty
Regulation Number: 886.4300
Classification Product Code: OTZ
Date Received: 05/30/2012
Decision Date: 10/03/2012
Regulation Medical Specialty: Ophthalmic
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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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