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510(k) K020318

SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES by Scivolutions, Inc. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2003
Date Received
January 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Scivolutions, Inc.

  • K082208 — DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER (December 1, 2008)

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