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510(k) K192527

Rochal Antimicrobial Wound Gel by Rochal Industries, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2020
Date Received
September 13, 2019
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

  • K182733 — Rochal Bioshield Silicone Film (June 27, 2019)
  • K161212 — Atteris Antimicrobial Skin Protectant (September 30, 2016)
  • K160192 — Atteris Antimicrobial Skin & Wound Cleanser (July 28, 2016)
  • K160684 — Atteris No-Sting Skin Protectant (July 26, 2016)

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