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FDA 510(k), K102971, FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
FDA 510(k), K102971, FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
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510(K) Number: K102971
Device Name: FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
Manufacturer: THOMAS B BONNER, JR.
Device Classification Name: Gown, Surgical
Regulation Number: FYA
Classification Product Code: 10/06/2010
Date Received: 02/23/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
Manufacturer: THOMAS B BONNER, JR.
Device Classification Name: Gown, Surgical
Regulation Number: FYA
Classification Product Code: 10/06/2010
Date Received: 02/23/2011
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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