Medical Device Manufacturer · US , San Antonio , TX

Rochal Industries, LLC

5 submissions · 5 cleared · Since 2016

Total

Cleared

Denied

Rochal Industries, LLC — FDA 510(k) Submissions

Rochal Industries, LLC has submitted 5 FDA 510(k) premarket notifications since 2016, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dressing, Wound, Drug, Bandage, Liquid . Use the specialty filter in the sidebar to narrow results.

5 devices

1–5 of 5

Rochal Antimicrobial Wound Gel

K192527 · FRO Dressing, Wound, Drug · General & Plastic Surgery

Feb 2020 147d

Rochal Bioshield Silicone Film

K182733 · KMF Bandage, Liquid · General & Plastic Surgery

Jun 2019 272d

Atteris Antimicrobial Skin Protectant

K161212 · FRO Dressing, Wound, Drug · General & Plastic Surgery

Sep 2016 155d

Atteris Antimicrobial Skin & Wound Cleanser