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FDA 510(k), K150914, Dash-Topic Plus Cream
FDA 510(k), K150914, Dash-Topic Plus Cream
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510(K) Number: K150914
Device Name: Dash-Topic Plus Cream
Manufacturer: Ronald M Gurge
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: KXA
Date Received: 04/06/2015
Decision Date: 04/21/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Dash-Topic Plus Cream
Manufacturer: Ronald M Gurge
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: KXA
Date Received: 04/06/2015
Decision Date: 04/21/2016
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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