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FDA 510(k)

MDA SIMPLASTIN HTF

K-Number: K974566 · 1998-02-24

ApplicantOrganon Teknika Corp.
Decision Date1998-02-24
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MDA SIMPLASTIN HTF is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1998-02-24 under 510(k) number K974566. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDA SIMPLASTIN HTF?

MDA SIMPLASTIN HTF is a medical device that received FDA 510(k) clearance on 1998-02-24. The listed applicant is Organon Teknika Corp.. The 510(k) number is K974566.

When did MDA SIMPLASTIN HTF receive FDA 510(k) clearance?

MDA SIMPLASTIN HTF received FDA 510(k) clearance on 1998-02-24, under 510(k) number K974566.

Who is the listed applicant for MDA SIMPLASTIN HTF?

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

What is the FDA product code for MDA SIMPLASTIN HTF?

The FDA product code for MDA SIMPLASTIN HTF is GJS.

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Other records listing Organon Teknika Corp. 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.

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Related Devices (Code: GJS)

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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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