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FDA 510(k), K142702, Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
FDA 510(k), K142702, Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
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510(K) Number: K142702
Device Name: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
Manufacturer: MEDIVANCE, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 09/22/2014
Decision Date: 12/18/2014
Regulation Medical Specialty: Cardiovascular
Device Name: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
Manufacturer: MEDIVANCE, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 09/22/2014
Decision Date: 12/18/2014
Regulation Medical Specialty: Cardiovascular
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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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