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510(k) K160192

Atteris Antimicrobial Skin & Wound Cleanser by Rochal Industries, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2016
Date Received
January 27, 2016
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 Rochal Industries, LLC

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  • K161212 — Atteris Antimicrobial Skin Protectant (September 30, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)

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