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FDA 510(k)

EPISIL

K-Number: K101769 · 2011-09-13

ApplicantCamurus AB
Decision Date2011-09-13
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

EPISIL is the device name listed in this FDA 510(k) record. The listed applicant is Camurus AB. It received FDA 510(k) clearance on 2011-09-13 under 510(k) number K101769. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPISIL?

EPISIL is a medical device that received FDA 510(k) clearance on 2011-09-13. The listed applicant is Camurus AB. The 510(k) number is K101769.

When did EPISIL receive FDA 510(k) clearance?

EPISIL received FDA 510(k) clearance on 2011-09-13, under 510(k) number K101769.

Who is the listed applicant for EPISIL?

The FDA 510(k) record lists Camurus AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPISIL?

The FDA product code for EPISIL is OLR.

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Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

Official Source

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

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