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FDA 510(k), K101309, EXELINT ALUMINUM HUB BLUNT NEEDLES
FDA 510(k), K101309, EXELINT ALUMINUM HUB BLUNT NEEDLES
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510(K) Number: K101309
Device Name: EXELINT ALUMINUM HUB BLUNT NEEDLES
Manufacturer: EXELINT INTERNATIONAL CO.
Device Classification Name: set, i.v. fluid transfer
Regulation Number: 880.5440
Classification Product Code: LHI
Date Received: 05/10/2010
Decision Date: 10/20/2010
Regulation Medical Specialty: General Hospital
Device Name: EXELINT ALUMINUM HUB BLUNT NEEDLES
Manufacturer: EXELINT INTERNATIONAL CO.
Device Classification Name: set, i.v. fluid transfer
Regulation Number: 880.5440
Classification Product Code: LHI
Date Received: 05/10/2010
Decision Date: 10/20/2010
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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