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FDA 510(k), K050104, APEX MEDICAL MININEB & MINIPLUS
FDA 510(k), K050104, APEX MEDICAL MININEB & MINIPLUS
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510(K) Number: K050104
Device Name: APEX MEDICAL MININEB & MINIPLUS
Manufacturer: ANAN CHANG
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: KXA
Date Received: 01/18/2005
Decision Date: 02/16/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: APEX MEDICAL MININEB & MINIPLUS
Manufacturer: ANAN CHANG
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: KXA
Date Received: 01/18/2005
Decision Date: 02/16/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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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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