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FDA 510(k), K160903, STERRAD 100NX Sterilizer with ALLClearTM Technology
FDA 510(k), K160903, STERRAD 100NX Sterilizer with ALLClearTM Technology
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510(K) Number: K160903
Device Name: STERRAD 100NX Sterilizer with ALLClearTM Technology
Manufacturer: JAMIE BYUN
Device Classification Name: Sterilizer, Chemical
Regulation Number: MLR
Classification Product Code: KXA
Date Received: 04/01/2016
Decision Date: 09/26/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: STERRAD 100NX Sterilizer with ALLClearTM Technology
Manufacturer: JAMIE BYUN
Device Classification Name: Sterilizer, Chemical
Regulation Number: MLR
Classification Product Code: KXA
Date Received: 04/01/2016
Decision Date: 09/26/2016
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
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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