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FDA 510(k)

Rochal Bioshield Silicone Film

K-Number: K182733 · 2019-06-27

ApplicantRochal Industries, LLC
Decision Date2019-06-27
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Rochal Bioshield Silicone Film is a medical device manufactured by Rochal Industries, LLC. It received FDA 510(k) clearance on 2019-06-27 under approval number K182733. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rochal Bioshield Silicone Film?

Rochal Bioshield Silicone Film is a medical device that received FDA 510(k) clearance on 2019-06-27. It is manufactured by Rochal Industries, LLC. The 510(k) number is K182733.

When was Rochal Bioshield Silicone Film approved by the FDA?

Rochal Bioshield Silicone Film received FDA 510(k) clearance on 2019-06-27, under approval number K182733.

What company makes Rochal Bioshield Silicone Film?

Rochal Bioshield Silicone Film is manufactured by Rochal Industries, LLC.

What is the FDA product code for Rochal Bioshield Silicone Film?

The FDA product code for Rochal Bioshield Silicone Film is KMF.

Other Devices by Rochal Industries, LLC

K161212Atteris Antimicrobial Skin Protectant K160192Atteris Antimicrobial Skin & Wound Cleanser K160684Atteris No-Sting Skin Protectant K192527Rochal Antimicrobial Wound Gel

Related Devices (Code: KMF)

K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC K171148Aleo BME Liquid BandageAleo Bme, Inc. K241916TearRepair Liquid Skin ProtectantOptmed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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