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FDA 510(k)

AURAFLEX TPO-AB

K-Number: K952607 · 1995-08-25

ApplicantOrganon Teknika Corp.
Decision Date1995-08-25
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AURAFLEX TPO-AB 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 1995-08-25 under 510(k) number K952607. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAFLEX TPO-AB?

AURAFLEX TPO-AB is a medical device that received FDA 510(k) clearance on 1995-08-25. The listed applicant is Organon Teknika Corp.. The 510(k) number is K952607.

When did AURAFLEX TPO-AB receive FDA 510(k) clearance?

AURAFLEX TPO-AB received FDA 510(k) clearance on 1995-08-25, under 510(k) number K952607.

Who is the listed applicant for AURAFLEX TPO-AB?

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 AURAFLEX TPO-AB?

The FDA product code for AURAFLEX TPO-AB is JNL.

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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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