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FDA 510(k)

ADHEROL SEPP APPLICATOR

K-Number: K952007 · 1995-06-08

ApplicantMedi-Flex Hospital Products, Inc.
Decision Date1995-06-08
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

ADHEROL SEPP APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Flex Hospital Products, Inc.. It received FDA 510(k) clearance on 1995-06-08 under 510(k) number K952007. 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 ADHEROL SEPP APPLICATOR?

ADHEROL SEPP APPLICATOR is a medical device that received FDA 510(k) clearance on 1995-06-08. The listed applicant is Medi-Flex Hospital Products, Inc.. The 510(k) number is K952007.

When did ADHEROL SEPP APPLICATOR receive FDA 510(k) clearance?

ADHEROL SEPP APPLICATOR received FDA 510(k) clearance on 1995-06-08, under 510(k) number K952007.

Who is the listed applicant for ADHEROL SEPP APPLICATOR?

The FDA 510(k) record lists Medi-Flex Hospital Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADHEROL SEPP APPLICATOR?

The FDA product code for ADHEROL SEPP APPLICATOR is FRO. This falls under the Anesthesiology category.

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Other records listing Medi-Flex Hospital 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.

K970441K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTHK962740DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641K952201PORT-A-CATH ACCESS KITK952416TRACHEOSTOMY CARE KITK952256PICC LINE KITK934790SEPP ADHESIVE REMOVER

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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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