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FDA 510(k), K150729, SpectraShield 9500 Surgical N95 Respirator
FDA 510(k), K150729, SpectraShield 9500 Surgical N95 Respirator
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$149.00 USD
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510(K) Number: K150729
Device Name: SpectraShield 9500 Surgical N95 Respirator
Manufacturer: Paul Sallarulo
Device Classification Name: N95 Respirator With Antimicrobial/Antiviral Agent
Regulation Number: ONT
Classification Product Code: 03/20/2015
Date Received: 12/29/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: SpectraShield 9500 Surgical N95 Respirator
Manufacturer: Paul Sallarulo
Device Classification Name: N95 Respirator With Antimicrobial/Antiviral Agent
Regulation Number: ONT
Classification Product Code: 03/20/2015
Date Received: 12/29/2015
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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