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: KXA
Date Received: 10/06/2010
Decision Date: 02/23/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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