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FDA 510(k), K180342, SYSTEM 1E Liquid Chemical Sterilant Processing System
FDA 510(k), K180342, SYSTEM 1E Liquid Chemical Sterilant Processing System
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$149.00 USD
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510(K) Number: K180342
Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System
Manufacturer: Jennifer Nalepka
Device Classification Name: Sterilant, Medical Devices
Regulation Number: MED
Classification Product Code: 02/07/2018
Date Received: 04/04/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System
Manufacturer: Jennifer Nalepka
Device Classification Name: Sterilant, Medical Devices
Regulation Number: MED
Classification Product Code: 02/07/2018
Date Received: 04/04/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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