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FDA 510(k), K053345, PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
FDA 510(k), K053345, PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
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510(K) Number: K053345
Device Name: PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
Manufacturer: MEDCOMP
Device Classification Name: catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Number: 880.5970
Classification Product Code: LJS
Date Received: 12/02/2005
Decision Date: 03/17/2006
Regulation Medical Specialty: General Hospital
Device Name: PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
Manufacturer: MEDCOMP
Device Classification Name: catheter, intravascular, therapeutic, long-term greater than 30 days
Regulation Number: 880.5970
Classification Product Code: LJS
Date Received: 12/02/2005
Decision Date: 03/17/2006
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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