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FDA 510(k), K181360, ON-Q* Pump with Bolus
FDA 510(k), K181360, ON-Q* Pump with Bolus
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$89.00 USD
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510(K) Number: K181360
Device Name: ON-Q* Pump with Bolus
Manufacturer: Neerav Parikh
Device Classification Name: Pump, Infusion, Elastomeric
Regulation Number: MEB
Classification Product Code: KXA
Date Received: 05/22/2018
Decision Date: 03/22/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: ON-Q* Pump with Bolus
Manufacturer: Neerav Parikh
Device Classification Name: Pump, Infusion, Elastomeric
Regulation Number: MEB
Classification Product Code: KXA
Date Received: 05/22/2018
Decision Date: 03/22/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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