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FDA 510(k)

TRIFLEX SELECT

K-Number: K070647 · 2007-06-22

ApplicantCardinal Health, Inc.
Decision Date2007-06-22
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIFLEX SELECT is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health, Inc.. It received FDA 510(k) clearance on 2007-06-22 under 510(k) number K070647. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIFLEX SELECT?

TRIFLEX SELECT is a medical device that received FDA 510(k) clearance on 2007-06-22. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K070647.

When did TRIFLEX SELECT receive FDA 510(k) clearance?

TRIFLEX SELECT received FDA 510(k) clearance on 2007-06-22, under 510(k) number K070647.

Who is the listed applicant for TRIFLEX SELECT?

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

What is the FDA product code for TRIFLEX SELECT?

The FDA product code for TRIFLEX SELECT is KGO.

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Other records listing Cardinal Health, Inc. as applicant

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Related Devices (Code: KGO)

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.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products Co., Ltd.

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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