FDA 510(k) K041059, EPI-MAX, by Dermagenics, Inc.
FDA 510(k) K041059, EPI-MAX, by Dermagenics, Inc.
Contents: Certified copy of the SE Clearance letter (510k letter) for K041059.
510(K) Number: K041059
Device Name: EPI-MAX
Manufacturer: Dermagenics, Inc.
Device Classification Name: Dressing, Wound, Drug
Classification Product Code: FRO
Date Received: 04/23/2004
Decision Date: 05/17/2005
Decision: Substantially Equivalent (SESE)
510k Review Panel: General & Plastic Surgery
5 Pages
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