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FDA 510(k), K220560, Dermatac Drape
FDA 510(k), K220560, Dermatac Drape
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$49.00 USD
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$49.00 USD
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510(K) Number: K220560
Device Name: Dermatac Drape
Manufacturer: Melanie Avila
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: KXA
Date Received: 02/28/2022
Decision Date: 07/14/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Dermatac Drape
Manufacturer: Melanie Avila
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: KXA
Date Received: 02/28/2022
Decision Date: 07/14/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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