510(k) K170407

BD ChloraShield IV Dressing with CHG Antimicrobial by Avery Dennison Belgie Bvba — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2017
Date Received
February 10, 2017
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