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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:
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:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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