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FDA 510(k)

FLEXHTR-1

K-Number: K894654 · 1990-08-01

Decision Date1990-08-01
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLEXHTR-1 is the device name listed in this FDA 510(k) record. The listed applicant is Bird Products Corp.. It received FDA 510(k) clearance on 1990-08-01 under 510(k) number K894654. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXHTR-1?

FLEXHTR-1 is a medical device that received FDA 510(k) clearance on 1990-08-01. The listed applicant is Bird Products Corp.. The 510(k) number is K894654.

When did FLEXHTR-1 receive FDA 510(k) clearance?

FLEXHTR-1 received FDA 510(k) clearance on 1990-08-01, under 510(k) number K894654.

Who is the listed applicant for FLEXHTR-1?

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

What is the FDA product code for FLEXHTR-1?

The FDA product code for FLEXHTR-1 is BZE.

Related Clinical Trials

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.

Other records listing Bird Products 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.

View all 35 devices →

Related Devices (Code: BZE)

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.

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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