FDA 510(k), K161067, Mirragen Advanced Wound Matrix, 4x4€, Mirragen Advanced Wound Matrix, 2x2€, Mirragen Advanced Wound Matrix, 1x6€

FDA 510(k), K161067, Mirragen Advanced Wound Matrix, 4x4€, Mirragen Advanced Wound Matrix, 2x2€, Mirragen Advanced Wound Matrix, 1x6€

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510(K) Number: K161067
Device Name: Mirragen Advanced Wound Matrix, 4x4€, Mirragen Advanced Wound Matrix, 2x2€, Mirragen Advanced Wound Matrix, 1x6€
Manufacturer: ENGINEERED TISSUE SOLUTIONS, LLC
Device Classification Name: absorbable synthetic wound dressing
Regulation Number:
Classification Product Code: QSZ
Date Received: 04/15/2016
Decision Date: 09/15/2016
Regulation Medical Specialty:
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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