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FDA 510(k)

TECNOL SALINE WET DRESSING

K-Number: K954243 · 1995-11-29

ApplicantTecnol Medical Products, Inc.
Decision Date1995-11-29
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

TECNOL SALINE WET DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol Medical Products, Inc.. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K954243. 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 TECNOL SALINE WET DRESSING?

TECNOL SALINE WET DRESSING is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Tecnol Medical Products, Inc.. The 510(k) number is K954243.

When did TECNOL SALINE WET DRESSING receive FDA 510(k) clearance?

TECNOL SALINE WET DRESSING received FDA 510(k) clearance on 1995-11-29, under 510(k) number K954243.

Who is the listed applicant for TECNOL SALINE WET DRESSING?

The FDA 510(k) record lists Tecnol Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECNOL SALINE WET DRESSING?

The FDA product code for TECNOL SALINE WET DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Tecnol Medical Products, 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.

K974068PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICALK970448PCM 2000; ISOLAIR APR MODEL 2735K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)K963556SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)

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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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