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FDA 510(k), K110623, PILLAR PALATAL IMPLANT SYSTEM
FDA 510(k), K110623, PILLAR PALATAL IMPLANT SYSTEM
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510(K) Number: K110623
Device Name: PILLAR PALATAL IMPLANT SYSTEM
Manufacturer: ROZANNE PACIEJ
Device Classification Name: Device, Anti-Snoring
Regulation Number: LRK
Classification Product Code: KXA
Date Received: 03/03/2011
Decision Date: 02/10/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: PILLAR PALATAL IMPLANT SYSTEM
Manufacturer: ROZANNE PACIEJ
Device Classification Name: Device, Anti-Snoring
Regulation Number: LRK
Classification Product Code: KXA
Date Received: 03/03/2011
Decision Date: 02/10/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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