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FDA 510(k), K951919, B-D PEN ULTRA
FDA 510(k), K951919, B-D PEN ULTRA
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510(K) Number: K951919
Device Name: B-D PEN ULTRA
Manufacturer: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Device Classification Name: Syringe, Piston
Regulation Number: 880.5860
Classification Product Code: FMF
Date Received: 04/24/1995
Decision Date: 10/24/1995
Regulation Medical Specialty: General Hospital
Device Name: B-D PEN ULTRA
Manufacturer: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
Device Classification Name: Syringe, Piston
Regulation Number: 880.5860
Classification Product Code: FMF
Date Received: 04/24/1995
Decision Date: 10/24/1995
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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