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FDA 510(k), K042547, DRAGON HEART PISTON SYRINGE
FDA 510(k), K042547, DRAGON HEART PISTON SYRINGE
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510(K) Number: K042547
Device Name: DRAGON HEART PISTON SYRINGE
Manufacturer: DRAGON HEART MEDICAL DEVICES CO., LTD.
Device Classification Name: syringe, piston
Regulation Number: 880.5860
Classification Product Code: FMF
Date Received: 09/20/2004
Decision Date: 12/01/2004
Regulation Medical Specialty: General Hospital
Device Name: DRAGON HEART PISTON SYRINGE
Manufacturer: DRAGON HEART MEDICAL DEVICES CO., LTD.
Device Classification Name: syringe, piston
Regulation Number: 880.5860
Classification Product Code: FMF
Date Received: 09/20/2004
Decision Date: 12/01/2004
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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