FDA 510(k)

TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N

K-Number: K061762 · 2006-08-01

Decision Date2006-08-01

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N 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 2006-08-01 under 510(k) number K061762. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N?

TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N is a medical device that received FDA 510(k) clearance on 2006-08-01. The listed applicant is Cardinal Health, Inc.. The 510(k) number is K061762.

When did TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N receive FDA 510(k) clearance?

TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N received FDA 510(k) clearance on 2006-08-01, under 510(k) number K061762.

Who is the listed applicant for TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N?

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 TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N?

The FDA product code for TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N is KKX.

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Other records listing Cardinal Health, Inc. as applicant

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Related Devices (Code: KKX)

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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.