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FDA 510(k), K192194, TotalShield II Surgical Helmet System
FDA 510(k), K192194, TotalShield II Surgical Helmet System
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$149.00 USD
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510(K) Number: K192194
Device Name: TotalShield II Surgical Helmet System
Manufacturer: Abigail Miller
Device Classification Name: Gown, Surgical
Regulation Number: FYA
Classification Product Code: 08/13/2019
Date Received: 10/15/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: TotalShield II Surgical Helmet System
Manufacturer: Abigail Miller
Device Classification Name: Gown, Surgical
Regulation Number: FYA
Classification Product Code: 08/13/2019
Date Received: 10/15/2019
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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