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FDA 510(k), K001293, MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
FDA 510(k), K001293, MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
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510(K) Number: K001293
Device Name: MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
Manufacturer: MEDIMOP MEDICAL PROJECTS, LTD.
Device Classification Name: set, i.v. fluid transfer
Regulation Number: 880.5440
Classification Product Code: LHI
Date Received: 04/24/2000
Decision Date: 05/05/2000
Regulation Medical Specialty: General Hospital
Device Name: MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
Manufacturer: MEDIMOP MEDICAL PROJECTS, LTD.
Device Classification Name: set, i.v. fluid transfer
Regulation Number: 880.5440
Classification Product Code: LHI
Date Received: 04/24/2000
Decision Date: 05/05/2000
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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