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FDA 510(k), K110424, DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
FDA 510(k), K110424, DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
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510(K) Number: K110424
Device Name: DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
Manufacturer: MEDCOMP (MEDICAL COMPONENTS)
Device Classification Name: Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation Number: 880.5965
Classification Product Code: LJT
Date Received: 02/14/2011
Decision Date: 11/30/2011
Regulation Medical Specialty: General Hospital
Device Name: DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL
Manufacturer: MEDCOMP (MEDICAL COMPONENTS)
Device Classification Name: Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation Number: 880.5965
Classification Product Code: LJT
Date Received: 02/14/2011
Decision Date: 11/30/2011
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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