FDA 510(k)

TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N

K-Number: K061308 · 2006-06-05

Decision Date2006-06-05

Product CodeFYA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health 200, Inc.. It received FDA 510(k) clearance on 2006-06-05 under 510(k) number K061308. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N?

TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N is a medical device that received FDA 510(k) clearance on 2006-06-05. The listed applicant is Cardinal Health 200, Inc.. The 510(k) number is K061308.

When did TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N receive FDA 510(k) clearance?

TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N received FDA 510(k) clearance on 2006-06-05, under 510(k) number K061308.

Who is the listed applicant for TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N?

The FDA 510(k) record lists Cardinal Health 200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N?

The FDA product code for TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N is FYA.

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Related Devices (Code: FYA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.