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FDA 510(k)

TPK 1980/1

K-Number: K822449 · 1982-10-27

ApplicantPlantex USA, Inc.
Decision Date1982-10-27
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TPK 1980/1 is the device name listed in this FDA 510(k) record. The listed applicant is Plantex USA, Inc.. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822449. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TPK 1980/1?

TPK 1980/1 is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Plantex USA, Inc.. The 510(k) number is K822449.

When did TPK 1980/1 receive FDA 510(k) clearance?

TPK 1980/1 received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822449.

Who is the listed applicant for TPK 1980/1?

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

What is the FDA product code for TPK 1980/1?

The FDA product code for TPK 1980/1 is LCX.

Related Devices (Code: LCX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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