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FDA 510(k), K133189, DUAL SHOT ALPHA 7
FDA 510(k), K133189, DUAL SHOT ALPHA 7
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510(K) Number: K133189
Device Name: DUAL SHOT ALPHA 7
Manufacturer: KEN WAKABAYASHI
Device Classification Name: Injector And Syringe, Angiographic
Regulation Number: DXT
Classification Product Code: KXA
Date Received: 10/17/2013
Decision Date: 06/30/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: DUAL SHOT ALPHA 7
Manufacturer: KEN WAKABAYASHI
Device Classification Name: Injector And Syringe, Angiographic
Regulation Number: DXT
Classification Product Code: KXA
Date Received: 10/17/2013
Decision Date: 06/30/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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