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FDA 510(k)

DONWAY SPLINT

K-Number: K843522 · 1985-02-07

ApplicantAustralian Biomedical Corporation , Ltd.
Decision Date1985-02-07
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DONWAY SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Australian Biomedical Corporation , Ltd.. It received FDA 510(k) clearance on 1985-02-07 under 510(k) number K843522. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DONWAY SPLINT?

DONWAY SPLINT is a medical device that received FDA 510(k) clearance on 1985-02-07. The listed applicant is Australian Biomedical Corporation , Ltd.. The 510(k) number is K843522.

When did DONWAY SPLINT receive FDA 510(k) clearance?

DONWAY SPLINT received FDA 510(k) clearance on 1985-02-07, under 510(k) number K843522.

Who is the listed applicant for DONWAY SPLINT?

The FDA 510(k) record lists Australian Biomedical Corporation , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DONWAY SPLINT?

The FDA product code for DONWAY SPLINT is ITH.

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Other records listing Australian Biomedical Corporation , Ltd. 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: ITH)

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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