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FDA 510(k)

DERMACYN WOUND IRRIGATION

K-Number: K042729 · 2005-05-17

ApplicantOculus Innovative Sciences, Inc.
Decision Date2005-05-17
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

DERMACYN WOUND IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Oculus Innovative Sciences, Inc.. It received FDA 510(k) clearance on 2005-05-17 under 510(k) number K042729. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMACYN WOUND IRRIGATION?

DERMACYN WOUND IRRIGATION is a medical device that received FDA 510(k) clearance on 2005-05-17. The listed applicant is Oculus Innovative Sciences, Inc.. The 510(k) number is K042729.

When did DERMACYN WOUND IRRIGATION receive FDA 510(k) clearance?

DERMACYN WOUND IRRIGATION received FDA 510(k) clearance on 2005-05-17, under 510(k) number K042729.

Who is the listed applicant for DERMACYN WOUND IRRIGATION?

The FDA 510(k) record lists Oculus Innovative Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMACYN WOUND IRRIGATION?

The FDA product code for DERMACYN WOUND IRRIGATION is FRO. This falls under the Anesthesiology category.

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Other records listing Oculus Innovative Sciences, Inc. 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.

K102945PEDIACYN ATOPIC DERMATITIS HYDROGELK093585MICROCYN SKIN AND WOUND HYDROGELK090206OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSERK090725OCULUS MICROCYN WOUND GELK060113DERMACYN WOUND CAREK041161MICROCYN WOUND CARE DRESSING

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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