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FDA 510(k), K070715, NASOPORE EAR
FDA 510(k), K070715, NASOPORE EAR
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510(K) Number: K070715
Device Name: NASOPORE EAR
Manufacturer: JAN NIEUWENHUIS
Device Classification Name: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Regulation Number: NHB
Classification Product Code: KXA
Date Received: 03/14/2007
Decision Date: 05/07/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: NASOPORE EAR
Manufacturer: JAN NIEUWENHUIS
Device Classification Name: Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Regulation Number: NHB
Classification Product Code: KXA
Date Received: 03/14/2007
Decision Date: 05/07/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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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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