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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 the device name listed in this FDA 510(k) record. The listed applicant is Rochal Industries, LLC. It received FDA 510(k) clearance on 2019-06-27 under 510(k) 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. The listed applicant is Rochal Industries, LLC. The 510(k) number is K182733.

When did Rochal Bioshield Silicone Film receive FDA 510(k) clearance?

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

Who is the listed applicant for Rochal Bioshield Silicone Film?

The FDA 510(k) record lists Rochal Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Rochal Industries, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192527Rochal Antimicrobial Wound GelK161212Atteris Antimicrobial Skin ProtectantK160192Atteris Antimicrobial Skin & Wound CleanserK160684Atteris No-Sting Skin Protectant

Related Devices (Code: KMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLC

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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