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FDA 510(k)

MDA SIMPLASTIN LS

K-Number: K952608 · 1995-10-06

ApplicantOrganon Teknika Corp.
Decision Date1995-10-06
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MDA SIMPLASTIN LS 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 1995-10-06 under 510(k) number K952608. 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 LS?

MDA SIMPLASTIN LS is a medical device that received FDA 510(k) clearance on 1995-10-06. The listed applicant is Organon Teknika Corp.. The 510(k) number is K952608.

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

MDA SIMPLASTIN LS received FDA 510(k) clearance on 1995-10-06, under 510(k) number K952608.

Who is the listed applicant for MDA SIMPLASTIN LS?

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 LS?

The FDA product code for MDA SIMPLASTIN LS 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)

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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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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