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FDA 510(k)

BACKSTOP AND BACKSTOP INJECTOR

K-Number: K090430 · 2009-06-02

ApplicantPluromed, Inc.
Decision Date2009-06-02
Product CodeONJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BACKSTOP AND BACKSTOP INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Pluromed, Inc.. It received FDA 510(k) clearance on 2009-06-02 under 510(k) number K090430. The device is classified under product code ONJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BACKSTOP AND BACKSTOP INJECTOR?

BACKSTOP AND BACKSTOP INJECTOR is a medical device that received FDA 510(k) clearance on 2009-06-02. The listed applicant is Pluromed, Inc.. The 510(k) number is K090430.

When did BACKSTOP AND BACKSTOP INJECTOR receive FDA 510(k) clearance?

BACKSTOP AND BACKSTOP INJECTOR received FDA 510(k) clearance on 2009-06-02, under 510(k) number K090430.

Who is the listed applicant for BACKSTOP AND BACKSTOP INJECTOR?

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

What is the FDA product code for BACKSTOP AND BACKSTOP INJECTOR?

The FDA product code for BACKSTOP AND BACKSTOP INJECTOR is ONJ.

Related Clinical Trials

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.

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Other records listing Pluromed, Inc. 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.

K110491BACKSTOP CATHETERK103349BACKSTOP CATHETERK090270BACKSTOP CATHETER, MODEL 60-0000-3100

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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