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FDA 510(k)

SPECTRUM TURBO-JECT PICC SET

K-Number: K100974 · 2010-05-06

ApplicantCook Incorporated
Decision Date2010-05-06
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPECTRUM TURBO-JECT PICC SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2010-05-06 under 510(k) number K100974. 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 SPECTRUM TURBO-JECT PICC SET?

SPECTRUM TURBO-JECT PICC SET is a medical device that received FDA 510(k) clearance on 2010-05-06. The listed applicant is Cook Incorporated. The 510(k) number is K100974.

When did SPECTRUM TURBO-JECT PICC SET receive FDA 510(k) clearance?

SPECTRUM TURBO-JECT PICC SET received FDA 510(k) clearance on 2010-05-06, under 510(k) number K100974.

Who is the listed applicant for SPECTRUM TURBO-JECT PICC SET?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRUM TURBO-JECT PICC SET?

The FDA product code for SPECTRUM TURBO-JECT PICC SET is FOZ.

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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.

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