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FDA 510(k), K082869, AWBAT-S, AWBAT-D, AWBAT-M
FDA 510(k), K082869, AWBAT-S, AWBAT-D, AWBAT-M
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510(K) Number: K082869
Device Name: AWBAT-S, AWBAT-D, AWBAT-M
Manufacturer: AUBREY, INC.
Device Classification Name: wound dressing with animal-derived material(s)
Regulation Number:
Classification Product Code: KGN
Date Received: 09/29/2008
Decision Date: 02/06/2009
Regulation Medical Specialty:
Device Name: AWBAT-S, AWBAT-D, AWBAT-M
Manufacturer: AUBREY, INC.
Device Classification Name: wound dressing with animal-derived material(s)
Regulation Number:
Classification Product Code: KGN
Date Received: 09/29/2008
Decision Date: 02/06/2009
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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