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FDA 510(k)

STRYKER T4 HYTREL TOGA

K-Number: K070078 · 2007-02-02

ApplicantStryker Instruments, Instruments Div.
Decision Date2007-02-02
Product CodeFYA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRYKER T4 HYTREL TOGA is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments, Instruments Div.. It received FDA 510(k) clearance on 2007-02-02 under 510(k) number K070078. 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 STRYKER T4 HYTREL TOGA?

STRYKER T4 HYTREL TOGA is a medical device that received FDA 510(k) clearance on 2007-02-02. The listed applicant is Stryker Instruments, Instruments Div.. The 510(k) number is K070078.

When did STRYKER T4 HYTREL TOGA receive FDA 510(k) clearance?

STRYKER T4 HYTREL TOGA received FDA 510(k) clearance on 2007-02-02, under 510(k) number K070078.

Who is the listed applicant for STRYKER T4 HYTREL TOGA?

The FDA 510(k) record lists Stryker Instruments, Instruments Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER T4 HYTREL TOGA?

The FDA product code for STRYKER T4 HYTREL TOGA is FYA.

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Other records listing Stryker Instruments, Instruments Div. 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.

K123178STRYKER VENOM ELECTRODES AND CANNULAEK113477IVAS 20MM (10 GAUGE) BALLOON CATHETERK093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVASK072702STRYKER ANTIMIC CATHETERK073017STRYKER STRI-SHIELD FLYTE TOGAS

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.

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