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FDA 510(k), K101532, NESSI OTC SPACER
FDA 510(k), K101532, NESSI OTC SPACER
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510(K) Number: K101532
Device Name: NESSI OTC SPACER
Manufacturer: PHARMACARIBE
Device Classification Name: Spacer, Direct Patient Interface
Regulation Number: 868.5630
Classification Product Code: NVO
Date Received: 06/03/2010
Decision Date: 09/01/2010
Regulation Medical Specialty: Anesthesiology
Device Name: NESSI OTC SPACER
Manufacturer: PHARMACARIBE
Device Classification Name: Spacer, Direct Patient Interface
Regulation Number: 868.5630
Classification Product Code: NVO
Date Received: 06/03/2010
Decision Date: 09/01/2010
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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