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FDA 510(k)

DRESSING CHANGE KIT

K-Number: K850887 · 1985-05-01

ApplicantCreative Care Systems, Inc.
Decision Date1985-05-01
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DRESSING CHANGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Creative Care Systems, Inc.. It received FDA 510(k) clearance on 1985-05-01 under 510(k) number K850887. 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 DRESSING CHANGE KIT?

DRESSING CHANGE KIT is a medical device that received FDA 510(k) clearance on 1985-05-01. The listed applicant is Creative Care Systems, Inc.. The 510(k) number is K850887.

When did DRESSING CHANGE KIT receive FDA 510(k) clearance?

DRESSING CHANGE KIT received FDA 510(k) clearance on 1985-05-01, under 510(k) number K850887.

Who is the listed applicant for DRESSING CHANGE KIT?

The FDA 510(k) record lists Creative Care Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRESSING CHANGE KIT?

The FDA product code for DRESSING CHANGE KIT is FOZ.

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Other records listing Creative Care Systems, 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.

K861406NON-KOR WINGED INFUSION SETSK852831NON-KOR ACCESS KITSK850888PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CVK841742NON-CORING NEEDLEK840919DAYPAK SYS VII CATHETER CARE KITK840681DAYPAK SYSTEM III CATHETER CARE KIT

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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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