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FDA 510(k), K151398, K-Pack II Needle - 29G x 5/16 Thin Wall
FDA 510(k), K151398, K-Pack II Needle - 29G x 5/16 Thin Wall
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510(K) Number: K151398
Device Name: K-Pack II Needle - 29G x 5/16 Thin Wall
Manufacturer: TERUMO EUROPE N.V.
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 05/26/2015
Decision Date: 06/25/2015
Regulation Medical Specialty: General Hospital
Device Name: K-Pack II Needle - 29G x 5/16 Thin Wall
Manufacturer: TERUMO EUROPE N.V.
Device Classification Name: needle, hypodermic, single lumen
Regulation Number: 880.5570
Classification Product Code: FMI
Date Received: 05/26/2015
Decision Date: 06/25/2015
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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