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FDA 510(k)

SIMPLASTIN L

K-Number: K915746 · 1992-02-12

ApplicantOrganon Teknika Corp.
Decision Date1992-02-12
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIMPLASTIN L 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 1992-02-12 under 510(k) number K915746. 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 SIMPLASTIN L?

SIMPLASTIN L is a medical device that received FDA 510(k) clearance on 1992-02-12. The listed applicant is Organon Teknika Corp.. The 510(k) number is K915746.

When did SIMPLASTIN L receive FDA 510(k) clearance?

SIMPLASTIN L received FDA 510(k) clearance on 1992-02-12, under 510(k) number K915746.

Who is the listed applicant for SIMPLASTIN L?

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 SIMPLASTIN L?

The FDA product code for SIMPLASTIN L 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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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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