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FDA 510(k)

ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS

K-Number: K861015 · 1986-04-22

ApplicantAcme United Corp.
Decision Date1986-04-22
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Acme United Corp.. It received FDA 510(k) clearance on 1986-04-22 under 510(k) number K861015. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS?

ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS is a medical device that received FDA 510(k) clearance on 1986-04-22. The listed applicant is Acme United Corp.. The 510(k) number is K861015.

When did ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS receive FDA 510(k) clearance?

ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS received FDA 510(k) clearance on 1986-04-22, under 510(k) number K861015.

Who is the listed applicant for ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS?

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

What is the FDA product code for ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS?

The FDA product code for ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS is FOZ.

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Other records listing Acme United Corp. 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.

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Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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